#mmsm #EHA26
MajesTEC-3 high risk post hoc analysis @RahulBanerjeeMD
Tec-Dara worked well in patients with 2HRCA or more as well as functionally high risk
Really goo
[Slide 1]
MajesTEC-3: PFS by Number of Expandedᵃ HRCAs
0 HRCAs
1 HRCA
≥2 HRCAs
Estimated
Estimated
Estimated
36-mo PFS rate
36-mo PFS rate
36-mo PFS rate
100
100
100
90.1%
Tec-Dara,
0 HRCAs
82.0%
80
80
Tec-Dara,
80
76.4%
1 HRCA
Tec-Dara,
% surviving without progression
>2 HRCAs
60
60
60
40
31.9%
40
40
30.7%
DPd/DVd,
0 HRCAs
DPd/DVd,
20
Tec-Dara, n=52
20
Tec-Dara, n=105
1 HRCA
20
Tec-Dara, n=64
13.7%
DPd/DVd, n=55
DPd/DVd. n=111
DPd/DVd, n=69
DPd/DVd,
HR, 0.12 (95% CI, 0.04-0.30)
HR, 0.19 (95% CI, 0.11-0.32)
HR, 0.16 (95% CI, 0.08-0.29)
>2 HRCAs
0
0
0
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45
Months
Months
Months
No. at risk
No. at risk
No. at risk
Tec-Dara
52
50
46
45
45
45
44
44
44
43
42
28
15
8
3
0
Tec-Dara 105 93 87 84 84 82 81 79 79 78 78 54 34 13 3 0 0
Tec-Dara
64 54 52 49 49 47 46 45 44 43 41 26 19 6 3 0
DPd/DVd
55
51
46
39
34
32
32
29
26
22
19
12
8
3
0
0
DPd/DVd 111 97 82 71 61 55 49 47 44 41 34 20 10 7 2 1 0
DPd/DVd
69 56 47 39 34 29 22 17 13 11 11 7 1 1 1 0
Tec-Dara consistently improved PFS vs DPd/DVd, including in patients with ultra high-risk RRMM
PHRCA number is defined as the number of abnormalities present from the following: del(17p). t(4;14), t(14;16), amp(1q21). or gain(1q21).
11
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
---
[Slide 2]
MajesTEC-3: PFS by Functional High-Risk Statusᵃ
Estimated
100
36-mo PFS rate
89.9%
Tec-Dara, not FHR
after 1 prior LOT
% surviving without progression
80
77.3%
Tec-Dara, FHR after 1 prior LOT
60
40
35.9%
&
DPd/DVd, not FHR
Not FHR after 1 prior LOT: Tec-Dara, n=82; DPd/DVd, n=94
after 1 prior LOT
20
HR, 0.11 (95% CI, 0.05-0.23)
0%
FHR after 1 prior LOT: Tec-Dara, n=26; DPd/DVd, n=20
DPd/DVd, FHR after 1 prior LOT
HR, 0.22 (95% CI, 0.08-0.62)
0
0
3
6
9
12
15
18
21
24
27
30
33
36
39
42
45
48
Months
No. at risk
Tec-Dara, not FHR after 1PL
82
78
78
77
77
74
74
72
71
70
69
46
30
15
3
0
0
DPd/DVd, not FHR after 1PL
94
86
73
65
59
53
47
45
39
38
36
24
13
7
2
1
0
Tec-Dara, FHR after 1PL
26
20
18
18
18
17
17
17
17
16
16
8
6
2
1
0
0
DPd/DVd, FHR after 1 PL
20
16
14
12
12
11
10
9
8
5
4
1
0
0
0
0
0
Tec-Dara substantially prolonged PFS vs DPd/DVd in patients with FHR MM,
surpassing inferior outcomes historically seen with traditional therapies¹
1PL, 1 prior LOT; MM, multiple myeloma. *Functional high-risk status defined as patients with 1 prior LOT and progressive disease within 18 months of ASCT or start of initial therapy. 1. Banerjee R, et al. Frontiers Oncol.
2023;13:1240966.
13
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
---
[Slide 3]
MajesTEC-3: PFS By Risk Status (ITT)
Tec-Dara
DPd/DVd
Events
Median
Events
Median
n/N
n/N
HR (95% CI)
PFS (mo)
PFS (mo)
Functional high risk
5/26
NE
14/20
23.2
0.22 (0.08-0.62)
Non-functional high risk
8/82
NE
57/94
20.8
0.11 (0.05-0.23)
Prespecified std. risk
15/126
NE
84/145
24.7
0.16 (0.09-0.27)
Prespecified high risk
20/104
NE
78/104
14.4
0.15 (0.09-0.25)
Expanded std. riskᵇ
5/52
NE
34/55
24.2
0.12 (0.04-0.30)
Expanded high riskb
30/169
NE
122/180
15.8
0.18 (0.12-0.26)
1 HRCA
17/105
NE
69/111
17.9
0.19 (0.11-0.32)
≥2 HRCAs
13/64
NE
53/69
14.4
0.16 (0.08-0.29)
0.01
0.1
1
10
Tec-Dara better DPd/DVd better
Tec-Dara consistently improved PFS vs DPd/DVd regardless of disease biology
CI, confidence interval; HR hazard ratio; ITT, intent-to-treat; NE, not estimable; Std., standard Prespecified standard risk: none of del(17p), t(4;14), or t(14;16). Prespecified high risk: >1 of del(17p), t(4;14), or t(14;16). Expanded
standard risk: none of del(17p), t(4;14), t(14;16), amp(1q21), or gain(1q21). Expanded high risk: >1 of del(17p), t(4;14), t(14;16), amp(1q21), or gain(1q21).
6
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
---
[Slide 4]
MajesTEC-3: PFS by Number of Expandedᵃ HRCAs
0 HRCAs
1 HRCA
≥2 HRCAs
Estimated
Estimated
Estimated
36-mo PFS rate
36-mo PFS rate
36-mo PFS rate
100
100
100
90.1%
Tec-Dara,
0 HRCAs
82.0%
80
80
Tec-Dara,
80
76.4%
1 HRCA
Tec-Dara,
% surviving without progression
>2 HRCAs
60
60
60
40
31.9%
40
40
30.7%
DPd/DVd,
0 HRCAs
DPd/DVd,
20
Tec-Dara, n=52
20
Tec-Dara, n=105
1 HRCA
20
Tec-Dara, n=64
13.7%
DPd/DVd, n=55
DPd/DVd. n=111
DPd/DVd, n=69
DPd/DVd,
HR, 0.12 (95% CI, 0.04-0.30)
HR, 0.19 (95% CI, 0.11-0.32)
HR, 0.16 (95% CI, 0.08-0.29)
>2 HRCAs
0
0
0
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45
Months
Months
Months
No. at risk
No. at risk
No. at risk
Tec-Dara
52
50
46
45
45
45
44
44
44
43
42
28
15
8
3
0
Tec-Dara 105 93 87 84 84 82 81 79 79 78 78 54 34 13 3 0 0
Tec-Dara
64 54 52 49 49 47 46 45 44 43 41 26 19 6 3 0
DPd/DVd
55
51
46
39
34
32
32
29
26
22
19
12
8
3
0
0
DPd/DVd 111 97 82 71 61 55 49 47 44 41 34 20 10 7 2 1 0
DPd/DVd
69 56 47 39 34 29 22 17 13 11 11 7 1 1 1 0
Tec-Dara consistently improved PFS vs DPd/DVd, including in patients with ultra high-risk RRMM
PHRCA number is defined as the number of abnormalities present from the following: del(17p). t(4;14), t(14;16), amp(1q21). or gain(1q21).
11
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
---
[Slide 5]
MajesTEC-3: PFS by Functional High-Risk Statusᵃ
Estimated
100
36-mo PFS rate
89.9%
Tec-Dara, not FHR
after 1 prior LOT
% surviving without progression
80
77.3%
Tec-Dara, FHR after 1 prior LOT
60
40
35.9%
&
DPd/DVd, not FHR
Not FHR after 1 prior LOT: Tec-Dara, n=82; DPd/DVd, n=94
after 1 prior LOT
20
HR, 0.11 (95% CI, 0.05-0.23)
0%
FHR after 1 prior LOT: Tec-Dara, n=26; DPd/DVd, n=20
DPd/DVd, FHR after 1 prior LOT
HR, 0.22 (95% CI, 0.08-0.62)
0
0
3
6
9
12
15
18
21
24
27
30
33
36
39
42
45
48
Months
No. at risk
Tec-Dara, not FHR after 1PL
82
78
78
77
77
74
74
72
71
70
69
46
30
15
3
0
0
DPd/DVd, not FHR after 1PL
94
86
73
65
59
53
47
45
39
38
36
24
13
7
2
1
0
Tec-Dara, FHR after 1PL
26
20
18
18
18
17
17
17
17
16
16
8
6
2
1
0
0
DPd/DVd, FHR after 1 PL
20
16
14
12
12
11
10
9
8
5
4
1
0
0
0
0
0
Tec-Dara substantially prolonged PFS vs DPd/DVd in patients with FHR MM,
surpassing inferior outcomes historically seen with traditional therapies¹
1PL, 1 prior LOT; MM, multiple myeloma. *Functional high-risk status defined as patients with 1 prior LOT and progressive disease within 18 months of ASCT or start of initial therapy. 1. Banerjee R, et al. Frontiers Oncol.
2023;13:1240966.
13
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
---
[Slide 6]
MajesTEC-3: PFS By Risk Status (ITT)
Tec-Dara
DPd/DVd
Events
Median
Events
Median
n/N
n/N
HR (95% CI)
PFS (mo)
PFS (mo)
Functional high risk
5/26
NE
14/20
23.2
0.22 (0.08-0.62)
Non-functional high risk
8/82
NE
57/94
20.8
0.11 (0.05-0.23)
Prespecified std. risk
15/126
NE
84/145
24.7
0.16 (0.09-0.27)
Prespecified high risk
20/104
NE
78/104
14.4
0.15 (0.09-0.25)
Expanded std. riskᵇ
5/52
NE
34/55
24.2
0.12 (0.04-0.30)
Expanded high riskb
30/169
NE
122/180
15.8
0.18 (0.12-0.26)
1 HRCA
17/105
NE
69/111
17.9
0.19 (0.11-0.32)
≥2 HRCAs
13/64
NE
53/69
14.4
0.16 (0.08-0.29)
0.01
0.1
1
10
Tec-Dara better DPd/DVd better
Tec-Dara consistently improved PFS vs DPd/DVd regardless of disease biology
CI, confidence interval; HR hazard ratio; ITT, intent-to-treat; NE, not estimable; Std., standard Prespecified standard risk: none of del(17p), t(4;14), or t(14;16). Prespecified high risk: >1 of del(17p), t(4;14), or t(14;16). Expanded
standard risk: none of del(17p), t(4;14), t(14;16), amp(1q21), or gain(1q21). Expanded high risk: >1 of del(17p), t(4;14), t(14;16), amp(1q21), or gain(1q21).
6
Presented by R Banerjee at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
⤢
Raj Chakraborty @rajshekharucms
Based on a recent slew of RCTs & updates at #ASCO26 and #EHA26 in relapsed #MultipleMyeloma, here is my framework for approaching 1st relapse (assuming access to all of t
[Slide 1]
Efficacy
DL1
DL2
Total
Response Rate
At DL2, 100% ORR and 83.3% CR achieved across DLBCL, MCL, and
(N=6)
(N=6)
(N=12)
FL
6 (100)
6 (50.0)
ORR, n (%) [95% CI]
0
[54.1-100]
[21.1-78.9]
Deepening response observed
CR, n (%)
5 (83.3)
5 (41.7)
0
[95% CI]
[35.9-99.6]
[15.2-72.3]
By data cutoff, all responses were ongoing
Percent Change from Baseline in SPD for Best Response (DL2)
Duration of Responses in Patients (DL2)
40
Pt 7: FL
20
Pt 8: FL
Change in target lesions from baseline (%)
0
Pt 9: DLBCL
-20
Pt 10: DLBCL
-40
Preevaluation
Pt 11: DLBCL
CR
-60
PR
Pt 12: MCL
Still being followed
-80
CR
CR
CR
-100
CR
CR
0
1
2
3
4
PR
Pt 10
Pt 11
Pt 8
Pt 12
Pt 7
Pt9
Months since infusion
DLBCL
DLBCL
FL
MCL
FL
DLBCL
The median follow-up for DL2 was 2.3 months (range, 2.0 to 4.5);
The Lugano 2014 criteria were used to assess the response at each prespecified time
Pt 8 had prior TCE with washout of 2.7 months
10
point in patients with NHL
---
[Slide 2]
Efficacy
DL1
DL2
Total
Response Rate
At DL2, 100% ORR and 83.3% CR achieved across DLBCL, MCL, and
(N=6)
(N=6)
(N=12)
FL
6 (100)
6 (50.0)
ORR, n (%) [95% CI]
0
[54.1-100]
[21.1-78.9]
Deepening response observed
CR, n (%)
5 (83.3)
5 (41.7)
0
[95% CI]
[35.9-99.6]
[15.2-72.3]
By data cutoff, all responses were ongoing
Percent Change from Baseline in SPD for Best Response (DL2)
Duration of Responses in Patients (DL2)
40
Pt 7: FL
20
Pt 8: FL
Change in target lesions from baseline (%)
0
Pt 9: DLBCL
-20
Pt 10: DLBCL
-40
Preevaluation
Pt 11: DLBCL
CR
-60
PR
Pt 12: MCL
Still being followed
-80
CR
CR
CR
-100
CR
CR
0
1
2
3
4
PR
Pt 10
Pt 11
Pt 8
Pt 12
Pt 7
Pt9
Months since infusion
DLBCL
DLBCL
FL
MCL
FL
DLBCL
The median follow-up for DL2 was 2.3 months (range, 2.0 to 4.5);
The Lugano 2014 criteria were used to assess the response at each prespecified time
Pt 8 had prior TCE with washout of 2.7 months
10
point in patients with NHL
⤢
Joshua Zeidner MD @LeukDocJZ
Congratulations to @Dr_AmerZeidan & KOMET-007 investigators. Great presentation showing excellent outcomes particularly in ND NPM1m AML pts Tx w/ 7+3+Ziftomenib supportin
[Slide 1]
Safety and Tolerability of Ziftomenib with 7+3
Grade ≥3 TEAEs in ≥10% of All Patients
Grade >3
NPM1-m
KMT2A-r
All Patients
Grade ≥3 AEs of Interest
Ziftomenib-related
n (%)
(N=49)
(N=50)
(N=99)
(N=99)
Differentiation syndrome (DS):
Any grade >3
46 (94)
49 (98)
95 (96)
52 (53)
4 Gr3 DS cases (4%; 1 NPM1-m,
Febrile neutropenia
29 (59)
33 (66)
62 (63)
13 (13)
3 KMT2A-r); no Gr4
Thrombocytopenia®
31 (63)
28 (56)
59 (60)
21 (21)
All DS events successfully resolved with
protocol-specified mitigation and 3
Anemia
20 (41)
17 (34)
37 (37)
15 (15)
continued ziftomenib treatment
Neutropenia
16 (33)
15 (30)
31 (31)
13 (13)
Amer M. Zeidan
Leukopenia
12 (24)
16 (32)
28 (28)
9 (9)
QTc prolongation:
ZIFTOMENIB COMBINED WITH INTENSIVE
Hypokalemia
5 (10)
10 (20)
15 (15)
1 (1)
3 Gr3 investigator-assessed QTc
INDUCTION (7+3) FOR NEWLY DIAGNOSED
Sepsis
6 (12)
7 (14)
13 (13)
4 (4)
prolongation cases (3%; 1 NPM1-m,
NPM1-M OR KMT2A-R ACUTE MYELOID
2 KMT2A-r; none ziftomenib-related);
Lymphopenia®
5 (10)
9 (18)
14 (14)
4 (4)
no Gr4
LEUKEMIA (AML): LONG-TERM RESULTS FROM
ALT increased
6 (12)
5 (10)
11 (11)
4 (4)
All QTc events successfully resolved and
THE KOMET-007 TRIAL
Pruritus
6 (12)
4 (8)
10 (10)
10 (10)
continued ziftomenib treatment
*Includes PTs platolet count decreased and thrombocytopenia *Includes PTs hemoglobin decreased red blood coll count decreased and anoma, includes neutrophil count decreased and neutropenia, *Includes while blood cell count decreased and
leukoponia, "Includes hymphocyte count decreased and tymphopenia Prunts was generally managed with gabapentin based (n-8) or antihistamine based (n-2) therapy All 3 patients were on other medications at time of QT assessment
(posaconazole, ciprofloxacin, levofloxacin, hydroxyzine, metronidazole): 1 patient had ongoing hypokalomia and hypomagnesemia
Data cutoff Apr 10. 2026 Gr, grade PT. preferred term QTc. corrected QT interval
EHA2026
eha
Congress
---
[Slide 2]
Clinical Activity of Ziftomenib with 7+3
NPM1-m
KMT2A-Γ
All Patients
n (%)
(N=49)
(N=50)
(N=99)
CRc
47 (96)
45 (90)
92 (93)
ORR
48 (98)
46 (92)
94 (95)
CR
46 (94)
41 (82)
87 (88)
CRh
1 (2)
1 (2)
2 (2)
CRi
0
3 (6)
3 (3)
MLFS
1 (2)
1 (2)
2 (2)
Amer M. Zeidan
PR
0
0
0
ZIFTOMENIB COMBINED WITH INTENSIVE
NR
1 (2)
3 (6)
4 (4)
INDUCTION (7+3) FOR NEWLY DIAGNOSED
NE
0
1 (2)
1 (1)
NPM1-M OR KMT2A-R ACUTE MYELOID
CR MRD negativity (local), n/m (%)a
39/46 (85)
30/35 (86)
69/81 (85)
LEUKEMIA (AML): LONG-TERM RESULTS FROM
CRc MRD negativity (local), n/m (%)a
THE KOMET-007 TRIAL
40/47 (85)
32/39 (82)
72/86 (84)
Median time to CR MRD negativity, months (range)
1.5 (0.5-12.2)
0.9 (0.5-2.8)
1.2 (0.5-12.2)
Median time to CRc MRD negativity, months (range)
1.5 (0.5-12.2)
0.9 (0.5-2.8)
1.1 (0.5-12.2)
Among evaluable responders tasted for MRD per local assay (NGS RT qPCR flow cytometry or FISH (KMT2A only])
Data cutoff Apr 10. 2026 FISH fluorescence in situ hybridization MRD. measurable residual disease, NE, not estimable NGS, next generation sequencing NR no response PR, partial remission RT qPCR quantitative reverse
transcription polymerase chain reaction
EHA2026
eha
Congress
---
[Slide 3]
Overall Survival
NPM1-m
1.0
After a median follow-up of 17.6 months
0.9
(range 1.0-23.5):
0.8
NPM1-m
Probability of overall survival
Median OS was not reached
0.7
0.6
- NPM1-m: 94% OS rate at 12 months
0.5
Median age was 60 years
0.4
Amer M. Zeidan
0.3
90% (44/49) of NPM1-m patients remained
0.2
alive and continued on study
ZIFTOMENIB COMBINED WITH INTENSIVE
Median OS, months (95% CI)
INDUCTION (7+3) FOR NEWLY DIAGNOSED
0.1
NPM1-m: Not reached (NE-NE)
- 60-day mortality: 2% (1/49)
O Censored
NPM1-M OR KMT2A-R ACUTE MYELOID
0.0
LEUKEMIA (AML): LONG-TERM RESULTS FROM
0
3
6
9
12
15
18
21
24
12-month OS with intensive chemotherapy-based
THE KOMET-007 TRIAL
Months
regimens varied from ~70-80% in younger/fit patients
Patients at Risk
to -45-55% in older adults1-5
NPM1-m 49
48
46
46
45
37
21
8
0
Patients on treatment or in long term follow up
Data cutoff Apr 10, 2026 os, overall survival
1. Othus of at Leukemia 2019. (3(2) 371-378 2. Othman et at Blood 2024 144(7) 714-728 3. Lachowiez et al Blood Adv 2020. 4(7) 1311-1320 4. Hemandez Sanchez et at. Leukemia 2026; 40(2) 418-428 5. Recher et at Leukemia 2022
36(4)913-922
EHA2026
eha
Congress
---
[Slide 4]
Overall Survival
KMT2A-r
1.0
After a median follow-up of 11.0 months
0.9
D
(range 0.9-21.9):
0.8
Probability of overall survival
Median OS was not reached
0.7
0.6
- KMT2A-r: 71% OS rate at 12 months
KMT2A-r
0.5
Median age was 43 years
0.4
Amer M. Zeidan
0.3
62% (31/50) of KMT2A-r patients remained
0.2
alive and continued on study
ZIFTOMENIB COMBINED WITH INTENSIVE
Median OS, months (95% CI)
0.1
KMT2A-r: Not reached (12.8-NE)
INDUCTION (7+3) FOR NEWLY DIAGNOSED
- 60-day mortality: 4% (2/50)
O Censored
NPM1-M OR KMT2A-R ACUTE MYELOID
0.0
LEUKEMIA (AML): LONG-TERM RESULTS FROM
0
3
6
9
12
15
18
21
24
THE KOMET-007 TRIAL
Months
Patients at Risk
KMT2A-Γ 50
47
38
33
23
13
3
1
0
Patients on treatment or in long term follow up
Data cutoff Apr 10, 2026 os, overall survival
EHA2026
eha
Congress
---
[Slide 5]
Safety and Tolerability of Ziftomenib with 7+3
Grade ≥3 TEAEs in ≥10% of All Patients
Grade >3
NPM1-m
KMT2A-r
All Patients
Grade ≥3 AEs of Interest
Ziftomenib-related
n (%)
(N=49)
(N=50)
(N=99)
(N=99)
Differentiation syndrome (DS):
Any grade >3
46 (94)
49 (98)
95 (96)
52 (53)
4 Gr3 DS cases (4%; 1 NPM1-m,
Febrile neutropenia
29 (59)
33 (66)
62 (63)
13 (13)
3 KMT2A-r); no Gr4
Thrombocytopenia®
31 (63)
28 (56)
59 (60)
21 (21)
All DS events successfully resolved with
protocol-specified mitigation and 3
Anemia
20 (41)
17 (34)
37 (37)
15 (15)
continued ziftomenib treatment
Neutropenia
16 (33)
15 (30)
31 (31)
13 (13)
Amer M. Zeidan
Leukopenia
12 (24)
16 (32)
28 (28)
9 (9)
QTc prolongation:
ZIFTOMENIB COMBINED WITH INTENSIVE
Hypokalemia
5 (10)
10 (20)
15 (15)
1 (1)
3 Gr3 investigator-assessed QTc
INDUCTION (7+3) FOR NEWLY DIAGNOSED
Sepsis
6 (12)
7 (14)
13 (13)
4 (4)
prolongation cases (3%; 1 NPM1-m,
NPM1-M OR KMT2A-R ACUTE MYELOID
2 KMT2A-r; none ziftomenib-related);
Lymphopenia®
5 (10)
9 (18)
14 (14)
4 (4)
no Gr4
LEUKEMIA (AML): LONG-TERM RESULTS FROM
ALT increased
6 (12)
5 (10)
11 (11)
4 (4)
All QTc events successfully resolved and
THE KOMET-007 TRIAL
Pruritus
6 (12)
4 (8)
10 (10)
10 (10)
continued ziftomenib treatment
*Includes PTs platolet count decreased and thrombocytopenia *Includes PTs hemoglobin decreased red blood coll count decreased and anoma, includes neutrophil count decreased and neutropenia, *Includes while blood cell count decreased and
leukoponia, "Includes hymphocyte count decreased and tymphopenia Prunts was generally managed with gabapentin based (n-8) or antihistamine based (n-2) therapy All 3 patients were on other medications at time of QT assessment
(posaconazole, ciprofloxacin, levofloxacin, hydroxyzine, metronidazole): 1 patient had ongoing hypokalomia and hypomagnesemia
Data cutoff Apr 10. 2026 Gr, grade PT. preferred term QTc. corrected QT interval
EHA2026
eha
Congress
---
[Slide 6]
Clinical Activity of Ziftomenib with 7+3
NPM1-m
KMT2A-Γ
All Patients
n (%)
(N=49)
(N=50)
(N=99)
CRc
47 (96)
45 (90)
92 (93)
ORR
48 (98)
46 (92)
94 (95)
CR
46 (94)
41 (82)
87 (88)
CRh
1 (2)
1 (2)
2 (2)
CRi
0
3 (6)
3 (3)
MLFS
1 (2)
1 (2)
2 (2)
Amer M. Zeidan
PR
0
0
0
ZIFTOMENIB COMBINED WITH INTENSIVE
NR
1 (2)
3 (6)
4 (4)
INDUCTION (7+3) FOR NEWLY DIAGNOSED
NE
0
1 (2)
1 (1)
NPM1-M OR KMT2A-R ACUTE MYELOID
CR MRD negativity (local), n/m (%)a
39/46 (85)
30/35 (86)
69/81 (85)
LEUKEMIA (AML): LONG-TERM RESULTS FROM
CRc MRD negativity (local), n/m (%)a
THE KOMET-007 TRIAL
40/47 (85)
32/39 (82)
72/86 (84)
Median time to CR MRD negativity, months (range)
1.5 (0.5-12.2)
0.9 (0.5-2.8)
1.2 (0.5-12.2)
Median time to CRc MRD negativity, months (range)
1.5 (0.5-12.2)
0.9 (0.5-2.8)
1.1 (0.5-12.2)
Among evaluable responders tasted for MRD per local assay (NGS RT qPCR flow cytometry or FISH (KMT2A only])
Data cutoff Apr 10. 2026 FISH fluorescence in situ hybridization MRD. measurable residual disease, NE, not estimable NGS, next generation sequencing NR no response PR, partial remission RT qPCR quantitative reverse
transcription polymerase chain reaction
EHA2026
eha
Congress
---
[Slide 7]
Overall Survival
NPM1-m
1.0
After a median follow-up of 17.6 months
0.9
(range 1.0-23.5):
0.8
NPM1-m
Probability of overall survival
Median OS was not reached
0.7
0.6
- NPM1-m: 94% OS rate at 12 months
0.5
Median age was 60 years
0.4
Amer M. Zeidan
0.3
90% (44/49) of NPM1-m patients remained
0.2
alive and continued on study
ZIFTOMENIB COMBINED WITH INTENSIVE
Median OS, months (95% CI)
INDUCTION (7+3) FOR NEWLY DIAGNOSED
0.1
NPM1-m: Not reached (NE-NE)
- 60-day mortality: 2% (1/49)
O Censored
NPM1-M OR KMT2A-R ACUTE MYELOID
0.0
LEUKEMIA (AML): LONG-TERM RESULTS FROM
0
3
6
9
12
15
18
21
24
12-month OS with intensive chemotherapy-based
THE KOMET-007 TRIAL
Months
regimens varied from ~70-80% in younger/fit patients
Patients at Risk
to -45-55% in older adults1-5
NPM1-m 49
48
46
46
45
37
21
8
0
Patients on treatment or in long term follow up
Data cutoff Apr 10, 2026 os, overall survival
1. Othus of at Leukemia 2019. (3(2) 371-378 2. Othman et at Blood 2024 144(7) 714-728 3. Lachowiez et al Blood Adv 2020. 4(7) 1311-1320 4. Hemandez Sanchez et at. Leukemia 2026; 40(2) 418-428 5. Recher et at Leukemia 2022
36(4)913-922
EHA2026
eha
Congress
---
[Slide 8]
Overall Survival
KMT2A-r
1.0
After a median follow-up of 11.0 months
0.9
D
(range 0.9-21.9):
0.8
Probability of overall survival
Median OS was not reached
0.7
0.6
- KMT2A-r: 71% OS rate at 12 months
KMT2A-r
0.5
Median age was 43 years
0.4
Amer M. Zeidan
0.3
62% (31/50) of KMT2A-r patients remained
0.2
alive and continued on study
ZIFTOMENIB COMBINED WITH INTENSIVE
Median OS, months (95% CI)
0.1
KMT2A-r: Not reached (12.8-NE)
INDUCTION (7+3) FOR NEWLY DIAGNOSED
- 60-day mortality: 4% (2/50)
O Censored
NPM1-M OR KMT2A-R ACUTE MYELOID
0.0
LEUKEMIA (AML): LONG-TERM RESULTS FROM
0
3
6
9
12
15
18
21
24
THE KOMET-007 TRIAL
Months
Patients at Risk
KMT2A-Γ 50
47
38
33
23
13
3
1
0
Patients on treatment or in long term follow up
Data cutoff Apr 10, 2026 os, overall survival
EHA2026
eha
Congress
[Slide 1]
Major safety signals, comorbidities and TKI choice
TKI
Safety signals
Guidance base on comorbidities
Rare or very rare: toxic/immune hepatitis,
Imatinib
Might help type 2 diabetes control
rhabdomyolysis, Stevens-Johnson syndrome
Low risk of arterial occlusive events
Frequent: long-term creatinine increase
Very frequent: diarrhea, hepatic cytolysis
Bosutinib
Frequent: pleural effusion, long-term creatinine increase
Avoid if kidney, GI or liver disease
Rare: precapillary PAH
Very frequent: Pleural (+/- pericardial) effusion
Dasatinib
Less frequent: lymph node hyperplasia, dysimmunity
Avoid if severe lung disease
Rare: precapillary PAH
Frequent: excess risk of ischemic CVE, diabetes,
Avoid if high CVD risk or established
Nilotinib
hypercholesterolemia
CVD, poorly controlled type 2 diabetes,
Less frequent: pancreatitis
recent or chronic pancreatitis
Rare: pericardial effusion
Asciminib
Less frequent: pancreatitis
Avoid if recent or chronic pancreatitis
Shah N, et al. JCO 2008; 26: 3204-3212
Giles et al. Leukemia 2013; 27: 1310-1315.
Kantarjian H, et al. NEJM 2010; 362: 2260-2270.
Saglio G, et al. Blood (ASH) 2013; 122: abstract 92.
Apperley JF, et al. Leukemia 2025; 39: 1797-1813.
Aichberger et al. Am J Hematol 2011; 86: 533-539.
Cortes JE, et al. NEJM 2013; 369: 1783-1796.
Le Coutre P, et al. JNCI 2011; 103: 1347-1348
Kantarjian H et al. Blood 2014; 123: 1309-1318.
Montani D, et al. Circulation 2012; 125: 2128-2137.
Rea D, et al. Ann Hematol 2015; 94 Suppl 2: S149-S158.
Kim D, et al. Leukemia 2013; 27: 1316-1321.
Valent P, et al. Blood 2015; 125: 901-906.
---
[Slide 2]
Major safety signals, comorbidities and TKI choice
TKI
Safety signals
Guidance base on comorbidities
Rare or very rare: toxic/immune hepatitis,
Imatinib
Might help type 2 diabetes control
rhabdomyolysis, Stevens-Johnson syndrome
Low risk of arterial occlusive events
Frequent: long-term creatinine increase
Very frequent: diarrhea, hepatic cytolysis
Bosutinib
Frequent: pleural effusion, long-term creatinine increase
Avoid if kidney, GI or liver disease
Rare: precapillary PAH
Very frequent: Pleural (+/- pericardial) effusion
Dasatinib
Less frequent: lymph node hyperplasia, dysimmunity
Avoid if severe lung disease
Rare: precapillary PAH
Frequent: excess risk of ischemic CVE, diabetes,
Avoid if high CVD risk or established
Nilotinib
hypercholesterolemia
CVD, poorly controlled type 2 diabetes,
Less frequent: pancreatitis
recent or chronic pancreatitis
Rare: pericardial effusion
Asciminib
Less frequent: pancreatitis
Avoid if recent or chronic pancreatitis
Shah N, et al. JCO 2008; 26: 3204-3212
Giles et al. Leukemia 2013; 27: 1310-1315.
Kantarjian H, et al. NEJM 2010; 362: 2260-2270.
Saglio G, et al. Blood (ASH) 2013; 122: abstract 92.
Apperley JF, et al. Leukemia 2025; 39: 1797-1813.
Aichberger et al. Am J Hematol 2011; 86: 533-539.
Cortes JE, et al. NEJM 2013; 369: 1783-1796.
Le Coutre P, et al. JNCI 2011; 103: 1347-1348
Kantarjian H et al. Blood 2014; 123: 1309-1318.
Montani D, et al. Circulation 2012; 125: 2128-2137.
Rea D, et al. Ann Hematol 2015; 94 Suppl 2: S149-S158.
Kim D, et al. Leukemia 2013; 27: 1316-1321.
Valent P, et al. Blood 2015; 125: 901-906.
[Slide 1]
EMN30/MajesTEC-4 SRI: Cumulative Incidence
of Grade 3/4 Infections
1.0
0.9
0.8
0.7
Cumulative incidence of
0.6
Tec Q4W + Len
Q4W + Len
grade 3/4 infections
Tec QW
0.5
0.4
0.3
0.2
0.1
Tec Q4W
0
0
3
6
9
12
15
18
21
24
27
30
33
36
Study month
Number at risk
6
5
4
0
32
28
25
25
23
19
14
14
Tec QW > Q4W + Len
Tec Q4W + Len
32
27
24
17
14
12
2
0
0
0
0
27
Tec Q4W
30
24
22
22
22
22
21
1
0
0
0
0
Cumulative incidence of grade 3/4 infections plateaued with Tec Q4W from ~6 months
10
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
---
[Slide 2]
EMN30/MajesTEC-4 SRI: Response Rates Post-ASCT and
During Maintenance
Efficacy data cutoff: December 8, 2025
60.0%
96.7%
100%
40.6%
96.9%
>CR rate
46.9%
10.0
sCR
100
12.5
CR
31.3
80
VGPR
28.1
50.0
75.0
76.7
PR
60
15.6
Patients (%)
93.8
40
43.8
34.4
23.3
20
21.9
20.0
18.8
15.6
3.1
16.7
3.3
6.3
0
Response
Best response
Response
Best response
Response
Best response
post-ASCT
on maintenance
post-ASCT
on maintenance
post-ASCT
on maintenance
Tec QW > Q4W + Len (n=32)
Tec Q4W + Len (n=32)
Tec Q4W (n=30)
Median follow-up, 35.3 mo
Median follow-up, 23.7 mo
Median follow-up, 23.7 mo
>CR was reached in nearly 100% of patients during maintenance across cohorts
sCR, stringent complete response; VGPR, very good partial response.
Response based on investigator assessment *Post-ASCT consolidation.
11
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
---
[Slide 3]
EMN30/MajesTEC-4 SRI: Progression-Free Survival
Estimated 18-mo Estimated 24-mo
96.4%
96.6%
100
Cohort 3:
Median PFS was not
90
Cohort 2:
Tec Q4W
93.8%
Cohort 1:
Tec Q4W +Len
Tec QW > Q4W +
reached in any cohort
80
Len
% of patients progression
70
Only 3 patients progressed
free and alive
60
- 2 in Cohort 1
50
40
- 1 in Cohort 3
30
20
10
0
0
3
6
9
12
15
18
21
24
27
30
33
Number at risk
PFS (months)
Tec QW + Q4W + Len
32
32
32
32
31
29
28
28
28
25
2
0
31
31
31
31
26
5
0
0
0
0
0
Tec Q4W + Len
32
Tec Q4W
30
29
28
27
26
26
6
0
0
0
0
0
Estimated 18- and 24-month PFS rates were 94%-97%, with only 3 progression events
Clinical cutoff date: May 7, 2025.
13
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
---
[Slide 4]
EMN30/Majes TEC-4 SRI: Tec ± Len as Maintenance
Therapy Post-ASCT in NDMM
Tec and Tec-Len were safety administered as 2-year fixed-duration post-ASCT maintenance, with convenient
Tec Q4W dosing after cycle 1 (median follow-up ~2-3 years)
CRS and infections were manageable via established protocols, supporting use across practice settings
Tec-based maintenance delivered remarkable depth of response post-ASCT, which deepened over time:
- -97%-100% of patients achieved >CR post-ASCT
- 90%-100% of evaluable patients achieved MRD-negative CR at 12 months
Estimated 18- and 24-mo PFS rates were 94%-97%, with only 3 progression events
The randomized portion is open and evaluating Tec-Len, Tec, and Len as maintenance with monthly Tec dosing
Tec + Len as post-ASCT maintenance in NDMM is a promising new maintenance approach
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
14
---
[Slide 5]
EMN30/MajesTEC-4 SRI: Cumulative Incidence
of Grade 3/4 Infections
1.0
0.9
0.8
0.7
Cumulative incidence of
0.6
Tec Q4W + Len
Q4W + Len
grade 3/4 infections
Tec QW
0.5
0.4
0.3
0.2
0.1
Tec Q4W
0
0
3
6
9
12
15
18
21
24
27
30
33
36
Study month
Number at risk
6
5
4
0
32
28
25
25
23
19
14
14
Tec QW > Q4W + Len
Tec Q4W + Len
32
27
24
17
14
12
2
0
0
0
0
27
Tec Q4W
30
24
22
22
22
22
21
1
0
0
0
0
Cumulative incidence of grade 3/4 infections plateaued with Tec Q4W from ~6 months
10
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
---
[Slide 6]
EMN30/MajesTEC-4 SRI: Response Rates Post-ASCT and
During Maintenance
Efficacy data cutoff: December 8, 2025
60.0%
96.7%
100%
40.6%
96.9%
>CR rate
46.9%
10.0
sCR
100
12.5
CR
31.3
80
VGPR
28.1
50.0
75.0
76.7
PR
60
15.6
Patients (%)
93.8
40
43.8
34.4
23.3
20
21.9
20.0
18.8
15.6
3.1
16.7
3.3
6.3
0
Response
Best response
Response
Best response
Response
Best response
post-ASCT
on maintenance
post-ASCT
on maintenance
post-ASCT
on maintenance
Tec QW > Q4W + Len (n=32)
Tec Q4W + Len (n=32)
Tec Q4W (n=30)
Median follow-up, 35.3 mo
Median follow-up, 23.7 mo
Median follow-up, 23.7 mo
>CR was reached in nearly 100% of patients during maintenance across cohorts
sCR, stringent complete response; VGPR, very good partial response.
Response based on investigator assessment *Post-ASCT consolidation.
11
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
---
[Slide 7]
EMN30/MajesTEC-4 SRI: Progression-Free Survival
Estimated 18-mo Estimated 24-mo
96.4%
96.6%
100
Cohort 3:
Median PFS was not
90
Cohort 2:
Tec Q4W
93.8%
Cohort 1:
Tec Q4W +Len
Tec QW > Q4W +
reached in any cohort
80
Len
% of patients progression
70
Only 3 patients progressed
free and alive
60
- 2 in Cohort 1
50
40
- 1 in Cohort 3
30
20
10
0
0
3
6
9
12
15
18
21
24
27
30
33
Number at risk
PFS (months)
Tec QW + Q4W + Len
32
32
32
32
31
29
28
28
28
25
2
0
31
31
31
31
26
5
0
0
0
0
0
Tec Q4W + Len
32
Tec Q4W
30
29
28
27
26
26
6
0
0
0
0
0
Estimated 18- and 24-month PFS rates were 94%-97%, with only 3 progression events
Clinical cutoff date: May 7, 2025.
13
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden
---
[Slide 8]
EMN30/Majes TEC-4 SRI: Tec ± Len as Maintenance
Therapy Post-ASCT in NDMM
Tec and Tec-Len were safety administered as 2-year fixed-duration post-ASCT maintenance, with convenient
Tec Q4W dosing after cycle 1 (median follow-up ~2-3 years)
CRS and infections were manageable via established protocols, supporting use across practice settings
Tec-based maintenance delivered remarkable depth of response post-ASCT, which deepened over time:
- -97%-100% of patients achieved >CR post-ASCT
- 90%-100% of evaluable patients achieved MRD-negative CR at 12 months
Estimated 18- and 24-mo PFS rates were 94%-97%, with only 3 progression events
The randomized portion is open and evaluating Tec-Len, Tec, and Len as maintenance with monthly Tec dosing
Tec + Len as post-ASCT maintenance in NDMM is a promising new maintenance approach
Presented by NWCJ van de Donk at the 31st European Hematology Association (EHA) Annual Meeting: June 11-14, 2026; Stockholm, Sweden
14
⤢
Breno Moreno de Gusmão @morenodegusmao
SUCCESSOR-2 #EHA2026
MeziKd vs Kd in anti-CD38 + LEN-exposed RRMM:
📊 PFS 18.0 vs 8.3 months (HR 0.48 | p<0.0001)
✅ ORR 80% | ≥CR 27% | VGPR doubled, CR tripled
Not com
[Slide 1]
SUCCESSOR-2: Treatment Response
ORR
80.2%
MeziKd
Kd
2 CR
ORR
(N 288)
(N 191)
80
26.7
53.4%
CR
Time to response, median
1.1
1.1
25
(range), monthsa
(0.7-7.4)
(0.9-7.9)
IV
CR
CR
72
54
8.9 VGPR
12-month DoR, % (95% CI)
(65-78)
(41-66)
8,4
2 VGPR
40
2 VGPR PR
33.3
60.1
22
30.9
Minimal residual disease analysis is ongoing, and
results will be reported in future presentations
20.1
22.5
0
MeziKd
Kd
(N 288)
(N = 191)
With a median follow up of 10.6 months, the addition of Mezi to Kd deepened response,
doubling the rate of VGPR or better and tripling the rate of CR or better
Data cuterf January 15, 2026. in the confirmatory analysis proup, defined as all patients from stages and randomized to mg Megi plus Kd or Kd. test overall response was evaluated by an independent review committee
Percentages may not total 100 due to rounding. aTime to response defined as the time from randomization the first unentation response PR better).
Dimopoutos MA, et al. EMA 2026, Presentation L85004
SUCCESSOR-2
SUCCESSOR-2: PFS2
Median PFS2
Hazard ratio
1.0
23.6 months
HR 0.53
antimyeloma
MeziKd
Kd
0.9
therapy, -
(N 288)
(N 191)
13.0 months
(95% CI, 0.39-0.72)
0.8
Any subsequent therapy
24.0
49.7
P
0.7
Bispecific antibodies
10.1
21.5
r
IMIDs
6.9
20.4
0
0.6
MeziKd
b
POM
5.6
18.3
0.5
a
LEN
0.3
1.0
b
0.4
Pls
6.6
11.0
0.3
Kd
Standard chemotherapyb
6.6
12.6
0.2
t
Other
4.9
8.9
y
0.1
Median follow-up: 10.6 months
Anti-CD38 mAbs
4.2
7.3
0
f
0
Investigational drugs
2.8
7.3
P
0
3
6
9
12
15
18
21
24
27
30
33
Anti-SLAME7 mAbs
1.4
5.8
F
Time (months)
No.
risk
CAR-T cell therapiesc
1.4
4.7
Mezikd
288
273
238
173
116
72
39
30
19
9
3
0
Antibody-drug conjugates
0.3
3.1
Kd
191
171
143
101
63
31
19
12
5
2
0
0
Superior PFS2 with MeziKd demonstrates sustained clinical benefit beyond first progression
Data cuteff: January 15. 2026. in the confirmatory analysis group, defined as all patients from stages and randomized to mg MO Kd or Kd. PF52 - per investigator assessment. aircludes subsequent antimyeloma therapies
that were received by of patients either treatment arm the confirmatory analysis paup, bistandard chemotherapy includes: nitrogen mustard analogs, anthracyclines and related substances, podophyllotoxin derivatives, platinum
compounds, purine analogs, and vinca alkaloids and analogs: cRefers to the output of "Cell and Gene therapies" CAR, chameric antigen receptor.
Dimopoutos MA, et at. DIA 2026, Presentation L85004
SUCCESSOR-2
SUCCESSOR-2: Overall Survival
1.0
000
0.9
0.8
P
0.7
O
0000
MeziK
r
-
OODO
0.6
0
DO 000 0000
00
0
-
Kd
b 0.5
No. of
Hazard ratio
a
0.4
62/288 (21.5%)
HR 0.79
b
il
0.3
51/191 (26.7%)
(95% CI, 0.54-1.15)
it
0.2
y
Median follow-up: 10.6 months
0.1
0
f
0
0
0
3
6
9
12
15
18
21
24
27
30
33
No. at visk
Time (months)
MeziK
28
27
24
18
12
79
45
35
25
12
5
0
Kd
B)
137
15
a
84
44
31
24
12
5
0
0
1
5
7
8
Planned futility analysis demonstrates a positive os trend favoring MeziKd with no cross over of the curves
Data cuteff: January 15, 2026. in the confirmatory analysis group, defined as all patients from stages and randomized to mg - plus Kd or Kd. Deaths occurred - 21.5% Mezikd) and 26.7% (Kd) of patients
Dimopoulos MA, et al. EHA 2026, Presentation LB5004
---
[Slide 2]
SUCCESSOR-2: Treatment Response
ORR
80.2%
MeziKd
Kd
2 CR
ORR
(N 288)
(N 191)
80
26.7
53.4%
CR
Time to response, median
1.1
1.1
25
(range), monthsa
(0.7-7.4)
(0.9-7.9)
IV
CR
CR
72
54
8.9 VGPR
12-month DoR, % (95% CI)
(65-78)
(41-66)
8,4
2 VGPR
40
2 VGPR PR
33.3
60.1
22
30.9
Minimal residual disease analysis is ongoing, and
results will be reported in future presentations
20.1
22.5
0
MeziKd
Kd
(N 288)
(N = 191)
With a median follow up of 10.6 months, the addition of Mezi to Kd deepened response,
doubling the rate of VGPR or better and tripling the rate of CR or better
Data cuterf January 15, 2026. in the confirmatory analysis proup, defined as all patients from stages and randomized to mg Megi plus Kd or Kd. test overall response was evaluated by an independent review committee
Percentages may not total 100 due to rounding. aTime to response defined as the time from randomization the first unentation response PR better).
Dimopoutos MA, et al. EMA 2026, Presentation L85004
SUCCESSOR-2
SUCCESSOR-2: PFS2
Median PFS2
Hazard ratio
1.0
23.6 months
HR 0.53
antimyeloma
MeziKd
Kd
0.9
therapy, -
(N 288)
(N 191)
13.0 months
(95% CI, 0.39-0.72)
0.8
Any subsequent therapy
24.0
49.7
P
0.7
Bispecific antibodies
10.1
21.5
r
IMIDs
6.9
20.4
0
0.6
MeziKd
b
POM
5.6
18.3
0.5
a
LEN
0.3
1.0
b
0.4
Pls
6.6
11.0
0.3
Kd
Standard chemotherapyb
6.6
12.6
0.2
t
Other
4.9
8.9
y
0.1
Median follow-up: 10.6 months
Anti-CD38 mAbs
4.2
7.3
0
f
0
Investigational drugs
2.8
7.3
P
0
3
6
9
12
15
18
21
24
27
30
33
Anti-SLAME7 mAbs
1.4
5.8
F
Time (months)
No.
risk
CAR-T cell therapiesc
1.4
4.7
Mezikd
288
273
238
173
116
72
39
30
19
9
3
0
Antibody-drug conjugates
0.3
3.1
Kd
191
171
143
101
63
31
19
12
5
2
0
0
Superior PFS2 with MeziKd demonstrates sustained clinical benefit beyond first progression
Data cuteff: January 15. 2026. in the confirmatory analysis group, defined as all patients from stages and randomized to mg MO Kd or Kd. PF52 - per investigator assessment. aircludes subsequent antimyeloma therapies
that were received by of patients either treatment arm the confirmatory analysis paup, bistandard chemotherapy includes: nitrogen mustard analogs, anthracyclines and related substances, podophyllotoxin derivatives, platinum
compounds, purine analogs, and vinca alkaloids and analogs: cRefers to the output of "Cell and Gene therapies" CAR, chameric antigen receptor.
Dimopoutos MA, et at. DIA 2026, Presentation L85004
SUCCESSOR-2
SUCCESSOR-2: Overall Survival
1.0
000
0.9
0.8
P
0.7
O
0000
MeziK
r
-
OODO
0.6
0
DO 000 0000
00
0
-
Kd
b 0.5
No. of
Hazard ratio
a
0.4
62/288 (21.5%)
HR 0.79
b
il
0.3
51/191 (26.7%)
(95% CI, 0.54-1.15)
it
0.2
y
Median follow-up: 10.6 months
0.1
0
f
0
0
0
3
6
9
12
15
18
21
24
27
30
33
No. at visk
Time (months)
MeziK
28
27
24
18
12
79
45
35
25
12
5
0
Kd
B)
137
15
a
84
44
31
24
12
5
0
0
1
5
7
8
Planned futility analysis demonstrates a positive os trend favoring MeziKd with no cross over of the curves
Data cuteff: January 15, 2026. in the confirmatory analysis group, defined as all patients from stages and randomized to mg - plus Kd or Kd. Deaths occurred - 21.5% Mezikd) and 26.7% (Kd) of patients
Dimopoulos MA, et al. EHA 2026, Presentation LB5004
[Slide 1]
Lessons Learned Thus Far
Overall survival remains extremely poor in BP-CML
There is tremendous heterogeneity in the biology and clinical presentation of BP-CML
No standard chemotherapy regimen has been identified
AlloSCT results in deeper molecular responses and improved OS and should be
employed whenever possible in patients in second CP
Data is conflicting on the need for chemotherapy plus TKI VS TKI monotherapy in patients
It appears that this is less relevant as long as patients are consolidated with alloSCT in second CP
More collaborative efforts are need to build larger data sets to assess ideal chemotherapy
regimens and preferred TKI
ELN BP-CML prognostic scoring system is predictive of outcomes and has been validated
by the H Jean Khoury Cure CML Consortium data set
Clinical trials are crucial in this space in order to develop better therapeutic options
We have a long way to go in order to improve outcomes for this group of patients.
---
[Slide 2]
Lessons Learned Thus Far
Overall survival remains extremely poor in BP-CML
There is tremendous heterogeneity in the biology and clinical presentation of BP-CML
No standard chemotherapy regimen has been identified
AlloSCT results in deeper molecular responses and improved OS and should be
employed whenever possible in patients in second CP
Data is conflicting on the need for chemotherapy plus TKI VS TKI monotherapy in patients
It appears that this is less relevant as long as patients are consolidated with alloSCT in second CP
More collaborative efforts are need to build larger data sets to assess ideal chemotherapy
regimens and preferred TKI
ELN BP-CML prognostic scoring system is predictive of outcomes and has been validated
by the H Jean Khoury Cure CML Consortium data set
Clinical trials are crucial in this space in order to develop better therapeutic options
We have a long way to go in order to improve outcomes for this group of patients.
[Slide 1]
Summary
BV and PD-1i proven to be efficacious with manageable toxicity
Desire is to use as early as possible in treatment pathway
At relapse, targeted agents, particularly PD-1i, are of benefit
Autograft still provides a curative approach
Cathy Burton
Treatment sequencing an
Probably can omit autograft for selected patients
transplant and cellular the
HL
Allografting limited to relapse after autograft
Retreatment is feasible especially if later relapse
CD30-directed CAR-T cells remain in clinical trial setting
---
[Slide 2]
Summary
BV and PD-1i proven to be efficacious with manageable toxicity
Desire is to use as early as possible in treatment pathway
At relapse, targeted agents, particularly PD-1i, are of benefit
Autograft still provides a curative approach
Cathy Burton
Treatment sequencing an
Probably can omit autograft for selected patients
transplant and cellular the
HL
Allografting limited to relapse after autograft
Retreatment is feasible especially if later relapse
CD30-directed CAR-T cells remain in clinical trial setting
[Slide 1]
Summary of 2L+ treatment
Aiming for ASCT remains standard approach at 2L
Aiming for CMR (achieving very good PR may be satisfactory)
Ideally PD-1i used either as monotherapy or concomitantly or sequentially with
chemotherapy if response to single agent is insufficient
Alternatively, if PD-1i not available, BV in combination with chemotherapy
---
[Slide 2]
Summary of 2L+ treatment
Aiming for ASCT remains standard approach at 2L
Aiming for CMR (achieving very good PR may be satisfactory)
Ideally PD-1i used either as monotherapy or concomitantly or sequentially with
chemotherapy if response to single agent is insufficient
Alternatively, if PD-1i not available, BV in combination with chemotherapy
[Slide 1]
Options post autograft: PD-1i
Nivolumab for R/R HL: CheckMate 205 study
Ansell et al. Blood Adv 2023
Allogeneic transplantation after PD-1 blockade
Nivo every 2 weeks until progression or toxicity
Merryman et al Leukaemia 2021
After prior BV or ASCT or ASCT/BV
209 patients
Improved outcomes from 2yr os of 65% to 82%
Pembrolizumab for R/R HL: KEYNOTE-087 study
Caution re GVHD
Armand et al Blood 2023
Post-transplant cyclophosphamide GVHD
Every 3 weeks for up to 2 years
prophylaxis associated with improved PFS
After prior ASCT/BV or salvage chemo/BV or ASCT
200+ patients
Checkpoint blockade sensitisation
ORR 71%, CRR approx. 25%
Carreau et al Oncologist 2020
Median DoR 16-18 months, PFS 13-15 months
5 year OS 71%
---
[Slide 2]
Options post autograft: PD-1i
Nivolumab for R/R HL: CheckMate 205 study
Ansell et al. Blood Adv 2023
Allogeneic transplantation after PD-1 blockade
Nivo every 2 weeks until progression or toxicity
Merryman et al Leukaemia 2021
After prior BV or ASCT or ASCT/BV
209 patients
Improved outcomes from 2yr os of 65% to 82%
Pembrolizumab for R/R HL: KEYNOTE-087 study
Caution re GVHD
Armand et al Blood 2023
Post-transplant cyclophosphamide GVHD
Every 3 weeks for up to 2 years
prophylaxis associated with improved PFS
After prior ASCT/BV or salvage chemo/BV or ASCT
200+ patients
Checkpoint blockade sensitisation
ORR 71%, CRR approx. 25%
Carreau et al Oncologist 2020
Median DoR 16-18 months, PFS 13-15 months
5 year OS 71%
⤢
Ahmed Kotb @AhmedKo45911157
📌 #EHA26 Infection Sources in HSCT
🔹Air, water, food, catheters, and close contacts are major infection sources.
🔹Common pathogens include Aspergillus, Candida, Pseudomon
[Slide 1]
09:15 - 10:45 Late-Breaking Oral Session
CHAIRS: MERITXELL ALBERICH JORDA, KONSTANZE DOHNER
Conclusions
BRUIN CLL-322 is the first randomized, phase 3 study to assess a fixed-duration targeted therapy
regimen in a CLL patient population with prior cBTKi exposure; results are from a prespecified interim
analysis
PVR demonstrated superiority in IRC-assessed PFS compared with VR (HR = 0.547) with 24-
month rates of PVR 86.9% VS VR 71.8%
The VR 24-month PFS rate is notably lower than that reported in MURANO (84.9%), reflecting the
mostly BTKi-pretreated population enrolled here
Matthew Davids
Consistent PVR PFS benefit across prespecified subgroups, including post-cBTKi, second-line, and
FIXED-DURATION PIRTOBRUTINIB PLUS
high-risk disease (unmutated IGHV, Del(17p) and/or TP53 mutation, complex karyotype)
VENETOCLAX-RITUXIMAB VERSUS VENETOCLAX-
RITUXIMAB FOR PATIENTS WITH PREVIOUSLY
Among patients with evaluable EOT samples, the uMRD4 rate was higher with PVR compared with
TREATED CLL/SLL: A PHASE 3, RANDOMIZED TRIAL
VR (86% [101/117] VS 61% [71/117]; P< 0.0001)
(BRUIN CLL-322)
PVR was well-tolerated with a safety profile consistent with the individual agents and no new safety
signals
These results establish PVR as a potential new standard of care option for patients with previously
treated CLL
EHA2026
eha
Congress
---
[Slide 2]
09:15 - 10:45 Late-Breaking Oral Session
CHAIRS: MERITXELL ALBERICH JORDA, KONSTANZE DOHNER
Conclusions
BRUIN CLL-322 is the first randomized, phase 3 study to assess a fixed-duration targeted therapy
regimen in a CLL patient population with prior cBTKi exposure; results are from a prespecified interim
analysis
PVR demonstrated superiority in IRC-assessed PFS compared with VR (HR = 0.547) with 24-
month rates of PVR 86.9% VS VR 71.8%
The VR 24-month PFS rate is notably lower than that reported in MURANO (84.9%), reflecting the
mostly BTKi-pretreated population enrolled here
Matthew Davids
Consistent PVR PFS benefit across prespecified subgroups, including post-cBTKi, second-line, and
FIXED-DURATION PIRTOBRUTINIB PLUS
high-risk disease (unmutated IGHV, Del(17p) and/or TP53 mutation, complex karyotype)
VENETOCLAX-RITUXIMAB VERSUS VENETOCLAX-
RITUXIMAB FOR PATIENTS WITH PREVIOUSLY
Among patients with evaluable EOT samples, the uMRD4 rate was higher with PVR compared with
TREATED CLL/SLL: A PHASE 3, RANDOMIZED TRIAL
VR (86% [101/117] VS 61% [71/117]; P< 0.0001)
(BRUIN CLL-322)
PVR was well-tolerated with a safety profile consistent with the individual agents and no new safety
signals
These results establish PVR as a potential new standard of care option for patients with previously
treated CLL
EHA2026
eha
Congress
⤢
CLL Ireland @CllIreland
Maybe a new #CLL treatment option presented at #EHA2026 as the results of clinical trial BRUIN CLL-322 show the drug combination PVR could change the standard of care fo
[Slide 1]
09:15 - 10:45 Late-Breaking Oral Session
CHAIRS: MERITXELL ALBERICH JORDA, KONSTANZE DOHNER
Conclusions
BRUIN CLL-322 is the first randomized, phase 3 study to assess a fixed-duration targeted therapy
regimen in a CLL patient population with prior cBTKi exposure; results are from a prespecified interim
analysis
PVR demonstrated superiority in IRC-assessed PFS compared with VR (HR = 0.547) with 24-
month rates of PVR 86.9% VS VR 71.8%
The VR 24-month PFS rate is notably lower than that reported in MURANO (84.9%), reflecting the
mostly BTKi-pretreated population enrolled here
Matthew Davids
Consistent PVR PFS benefit across prespecified subgroups, including post-cBTKi, second-line, and
FIXED-DURATION PIRTOBRUTINIB PLUS
high-risk disease (unmutated IGHV, Del(17p) and/or TP53 mutation, complex karyotype)
VENETOCLAX-RITUXIMAB VERSUS VENETOCLAX-
RITUXIMAB FOR PATIENTS WITH PREVIOUSLY
Among patients with evaluable EOT samples, the uMRD4 rate was higher with PVR compared with
TREATED CLL/SLL: A PHASE 3, RANDOMIZED TRIAL
VR (86% [101/117] VS 61% [71/117]; P< 0.0001)
(BRUIN CLL-322)
PVR was well-tolerated with a safety profile consistent with the individual agents and no new safety
signals
These results establish PVR as a potential new standard of care option for patients with previously
treated CLL
EHA2026
eha
Congress
---
[Slide 2]
09:15 - 10:45 Late-Breaking Oral Session
CHAIRS: MERITXELL ALBERICH JORDA, KONSTANZE DOHNER
Conclusions
BRUIN CLL-322 is the first randomized, phase 3 study to assess a fixed-duration targeted therapy
regimen in a CLL patient population with prior cBTKi exposure; results are from a prespecified interim
analysis
PVR demonstrated superiority in IRC-assessed PFS compared with VR (HR = 0.547) with 24-
month rates of PVR 86.9% VS VR 71.8%
The VR 24-month PFS rate is notably lower than that reported in MURANO (84.9%), reflecting the
mostly BTKi-pretreated population enrolled here
Matthew Davids
Consistent PVR PFS benefit across prespecified subgroups, including post-cBTKi, second-line, and
FIXED-DURATION PIRTOBRUTINIB PLUS
high-risk disease (unmutated IGHV, Del(17p) and/or TP53 mutation, complex karyotype)
VENETOCLAX-RITUXIMAB VERSUS VENETOCLAX-
RITUXIMAB FOR PATIENTS WITH PREVIOUSLY
Among patients with evaluable EOT samples, the uMRD4 rate was higher with PVR compared with
TREATED CLL/SLL: A PHASE 3, RANDOMIZED TRIAL
VR (86% [101/117] VS 61% [71/117]; P< 0.0001)
(BRUIN CLL-322)
PVR was well-tolerated with a safety profile consistent with the individual agents and no new safety
signals
These results establish PVR as a potential new standard of care option for patients with previously
treated CLL
EHA2026
eha
Congress
⤢
Myeloma Patients Europe @MyelomaEurope
“There is heterogeneity in approvals of important and innovative myeloma drugs across Europe.” Prof Pieter Sonneveld opens the #EHA26 #myeloma access session.
Highest-impact physician tweets by blood cancer subtype. Expand the Clinical Trials section under each disease area to drill into trial-specific discussion.
NEJM @NEJM
Samer Al Hadidi, MD,MS,FACP @HadidiSamer
Raj Chakraborty @rajshekharucms
Eddie Cliff @Eddie_Cliff
Joshua Zeidner MD @LeukDocJZ
Benlazar S M A @smbenlazar
Daniel Auclair @AuclairDan
Breno Moreno de Gusmão @morenodegusmao
Mostafa Faisal @MostafaFaisal14
Ahmed Kotb @AhmedKo45911157
Raul Cordoba, MD, PhD #EHA2026 @DrRaulCordoba
CLL Ireland @CllIreland
Myeloma Patients Europe @MyelomaEurope
Simon C@scserendipity1
Kate Sears@MedwatchKate
Santhosh Ambika@RenoHemonc
Hira Mian@HiraSMian
Michael H. Tomasson, MD@MTomasson
Rafael Fonseca MD 🦔🇺🇸🏜🇲🇽@Rfonsi1
Barb Kennedy@b_2boysmom1310
Beth Faiman PhD@Bethfaiman
