VIKTORIA-1 Trial

[Slide 1] SABCS 2025 METASTATIC HR+ HIGHLIGHTS Study Patient Population Treatment / Comparator Key Findings HR+/HER2+ with high - PFS 7mos vs. 13.9mos (HR 0.67) Chemo + maint ET AMBRE tumor burden - ORR 29.2% VS. 35.2% vs. (involving visceral - DoR 7.4mos vs. 10.9mos (HR 0.46, ET + Abemaciclib sites) p=0.023) - PFS with ILC 20.5mos vs. 9.4mos (HR 0.56) MONALEESA-3 - PFS with ILC 1L pts 59.6mos vs. Ribociclib + Fulvestrant HR+/HER2- ABC post 40mos (HR 0.54) Update vs. ET - OS with ILC 51.2mos vs. 30.8mos (ILC Subtype) Placebo + Fulvestrant (HR 0.62) - OS with ILC 1L pts 59.6mos vs. 40mos (HR 0.54) HR+/HER2- ABC Gedatolisib + Palbo + Fulv - PFS by bone mets status triplet NR progression on/after VS. VS. NR VS. 8.2mos VIKTORIA-1 CDK4/6i + NSAI, <2 Gedatolisib + Fulv - PFS in non-bone mets 9.3mos VS. prior ET for ABC, VS. 7.3mos VS. 1.9mos PIK3CA WT Fulv alone Camizestrant + CDK4/6i - Time to first subsequent therapy HR+/HER2- ABC post 16.6mos. VS. 9.2mos SERENA-6 AI + CKD4/6i for at vs. AI + CDK4/6i - Time to second subsequent least 6mos with ESRlm therapy 25.7mos vs. 19.4mos - PFS in ESRlm 9.99mos vs. 5.45mos HR+/HER- ABC <2 Giredestrant + Everolimus - PFS in ITT 8.77mos VS. 5.49mos prior lines of ET, evERA vs. - PFS in duration of prior CDK4/6i progressive disease ET + Everolimus <12mos, 5.55mos VS. 3.8lmos during/post CDK4/6i - PFS in duration of prior CDK4/6i 212mos 9.23mos VS. 5.55mos ER+, HER2- ABC - OS in all patients, NR vs. 34.4mos recurrence on or Imlunestrant + Abemaciclib - PFS with ESRlm 11.1mos vs. 5.5mos EMBER-3 after 12 mos of vs. (HR 0.49) completion of AI+/- Imlunestrant - PFS without ESRlm 9.2mos vs. CDK4/6i 5.5mos (HR 0.64) Sacituzumab HR+/HER2-, ABC post - 12mos PFS rate by BICR 40% VS. ASCENT-07 VS. 37% (HR 0.85, p=0.130) ET Physician's choice - OS NR VS. NR (HR 0.72, p=0.029) Website: ONC x @OncBrothers www.oncbrothers.com

[Slide 1] VIKTORIA-1 Study Design HR+/HER2- Arm At Advanced Breast Cancer Gedatolisib 180 mg IV once weekly, 3 weeks on, 1 week off Primary Endpoints Eligibility Criteria Palbociclib 125 mg daily, 21 days on, 7 days off PFS (BICR) Pre- & postmenopausal women & men Fulvestrant 500 mg; cycle 1, days 1 & 15, then Arm A VS. Arm C Progression on/after CDK4/6i + NSAI every 4 weeks Arm B vs. Arm C STUDY 1 R 1:1:1 Arm Bt ≤2 lines of prior ET for ABC PIK3CA-WT (N=392) Gedatolisib 180 mg IV once weekly, Secondary Endpoints Measurable disease, RECIST v1.1 3 weeks on, 1 week off Screening result for PIK3CA status Fulvestrant 500 mg; cycle 1, days 1 & 15, then OS every 4 weeks No T2DM with HbA1c >6.4% or T1DM Response Arm C Safety No prior mTORi, PI3Ki, or AKTi Assign Fulvestrant 500 mg; cycle 1, days 1 & 15, then every 4 weeks QoL No prior chemotherapy for ABC Optional cross-over to Arm A or B at progression Stratification Factors Gedatolisib1 + Palbociclib + Fulvestrant Lung/liver metastases (yes/no) STUDY 2 R3:13 Gedatolisib + Fulvestrant TTP on immediate prior therapy (≤ or >6 months) PIK3CA-MT Region (US/Canada or ROW) Alpelisib Fulvestrant Prophylactic use of a steroid-containing "swish and spit" regimen was protocol-mandated; oral non-sedating antihistamine therapy was recommended Abbreviations: 2-negative; HR+, ABC, hormone advanced receptor-positive; breast cancer, IV, AKTi, intravenous; protein kinase MT, 8 inhibitor; BICR, blinded independent central review; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; ET, endocrine therapy; HbA1c, hemoglobin A1c; HER2-, human quality of life; R, randomization; ROW, rest of world; 1 mutated; diabetes mTORi, mechanistic target of rapamycin inhibitor; NSAI, non-steroidal aromatase inhibitor; OS, overall survival; PFS, progression-free survival; PI3Ki, phosphalidylinositol epidermal 3-kinase growth inhibitor; factor receptor QoL, T1DM, type mellitus; T2DM, type 2 diabetes mellitus; TTP, time to progression; WT, wild-type Presenter: Sara A. Hurvitz, MD, FACP Content of this presentation is copyrighted and responsibility of the author. Permission is required for re-use. BERLIN --- [Slide 2] Baseline Demographics and Disease Characteristics Gedatolisib + Palbo Gedatolisib + Gedatolisib + Palbo + Gedatolisib + Fulvestrant Characteristic + Fulvestrant Fulvestrant Fulvestrant (n=131) Characteristic Fulvestrant Fulvestrant (n=131) (n=130) (n=131) (n=131) (n=130) Age, yr, median (range) 57 (33-83) 57 (32-81) 54 (28-83) Liver or lung mets, n (%) 102 (77.9) 104 (80.0) 109 (83.2) Female sex, n (%) 129 (98.5) 130 (100) 128 (97.7) Prior (neo)adjuvant tx, n (%) Postmenopausal, n (%) 101 (77.1) 93 (71.5) 92 (70.2) Chemotherapy 33 (25.2) 39 (30.0) 38 (29.0) Race/ethnic group, n (%) Endocrine therapy 46 (35.1) 57 (43.8) 64 (48.9) White 85 (64.9) 95 (73.1) 95 (72.5) Prior lines, ET for ABC, n (%) Asian 18 (13.7) 19 (14.6) 25 (19.1) 0 3 (2.3) 2 (1.5) 4 (3.1) Black/African American 1 5 (3.8) 3 (2.3) 1 (0.8) 113 (86.3) 113 (86.9) 115 (87.8) 2 Other/Unknown 15 (11.5) 15 (11.5) 23 (17.6) 13 (10.0) 10 (7.6) 12 (9.2) TTP on immediate prior tx, n Geographic region, n (%) (%) United States/Canada 21 (16.0) 21 (16.2) 22 (16.8) <6 months 21 (16.0) 19 (14.6) 20 (15.3) Asia Pacific 18 (13.7) 18 (13.8) 26 (19.8) >6 months 109 (83.2) 111 (85.4) 111 (84.7) Latin America 35 (26.7) 36 (27.7) 35 (26.7) Prior adjuvant CDK4/6i, n (%) 3 (2.3) 6 (4.6) 4 (3.1) Europe 57 (43.5) 55 (42.3) 48 (36.6) Prior CDK4/6i for ABC, n (%) Palbociclib 56 (42.7) 47 (36.2) 52 (39.7) ABC at diagnosis, n (%) 63 (48.1) 51 (39.2) 45 (34.4) Ribociclib 59 (45.0) 62 (47.7) 70 (53.4) ECOG PS score, n (%) Abemaciclib 23 (17.6) 26 (20.0) 16 (12.2) 0 70 (53.4) 85 (65.4) 77 (58.8) Prior CDK4/6i for ABC, mo., 1 61 (46.6) 45 (34.6) 54 (41.2) 21.7 (13.7-35.0) median duration (IQR) 18.1 (10.8-30.0) 20.0 (12.0-34.2) Abbreviations: ABC, advanced breast cancer; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; ECOG PS, Eastern Cooperative Oncology Group Performance Status; ET, endocrine therapy; IQR, interquartile range; mets, metastases; mo., months; Palbo, palbociclib; TTP. time to disease progression; tx, therapy, yr, years Presenter: Sara A. Hurvitz, MD, FACP ESMD congress Content of this presentation is copyrighted and responsibility of the author. Permission is required for re-use --- [Slide 3] 1st Co-Primary Endpoint: Progression-Free Survival Gedatolisib Triplet vs. Fulvestrant, BICR Assessment 100 Geda + Palbo + Fulvestrant Fulvestrant 90 (n=131) (n=131) 80 9.3 2.0 Median PFS, months (95% CI) (7.2-16.6) (1.8-2.3) 70 Adjusted HR (95% CI) 0.24 (0.17-0.35); P< 0.0001 Progression-free Survival (%) 60 50 40 30 20 10 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Months No. at Risk: Geda + Palbo + Fulv 131 127 103 94 69 68 50 49 35 34 24 22 19 16 10 10 9 6 6 6 4 4 4 1 0 Fulv 131 114 45 35 20 20 11 11 7 5 3 2 2 2 1 1 1 0 enter: Sara A. Hurvitz, MD, FACP ESMO congress nf of this presentation is copyrighted and responsibility of the author. Permission is required for re-use --- [Slide 4] 2nd Co-Primary Endpoint: Progression-Free Survival Gedatolisib Doublet vs. Fulvestrant, BICR Assessment Gedatolisib + 100 Fulvestrant Fulvestrant 90 (n=130) (n=131) 7.4 2.0 80 Median PFS, months (95% CI) (5.5-9.9) (1.8-2.3) 70 on-free Survival (%) Adjusted HR (95% CI) 0.33 (0.24-0.48); P < 0.0001 60 50 40 30 20 10 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Months sk: IV 130 126 93 89 64 63 45 44 33 33 22 22 17 16 11 8 6 5 5 3 1 1 1 1 1 1 0 V 131 114 45 35 20 20 11 11 7 5 3 2 2 2 1 1 1 0 urvitz, MD, FACP ESMD congress tion is copyrighted and responsibility of the author. Permission is required for re-use

[Slide 1] VIKTORIA-1 results PFS Gedatolisib Triplet vs. Fulvestrant PFS Gedatolisib Doublet vs. Fulvestrant 100-1 Deda Pallse+ Fulvestrent Fulvestrant 100 I (ent21) Furvestment Fulvestrant 90-5 (14131) * (=130) (AME31) : 50- 9.3 2.0 Median PFS, months (95% CI) 7.4 (7.2-16.6) 10- 2.0 (1.8-2.3) Median PFS. months (95% CI) 70" (5.5-9) (1.8-2.3) Adjusted HR (95% City 0.24 (0. 17-0.35); P. 0.0001 & Progression-free Survival (%) 50- Burrival 2 Adjusted HR (95% CI) 0.33 (0.24-0.48); 1.0001 50- 8 8 40" 40- 30- * 20- 20- 10- 1 0- 0- 0 2 3 4 5 6 8 9 10 11 12 13 14 15 16 17 18 # 20 5 22 23 24 0 / 3 4 $ 7 a 9 10 11 12 13 14 15 , 17 18 19 20 21 22 23 24 25 26 Months No. Months - Code 121 17 - - to - 50 - 30 - - 22 10 - - - - - 114 - 20 " " . II an Interim OS Censored at Cross-Over Interim OS Censored at Cross-Over Gedatolisib Triplet vs. Fulvestrant Geda Palbo Gedatolisib Doublet vs. Fulvestrant Goda Fulvestrant Fulvestrant Pulvestrant Fulvestrant (n=131) (пртат) n=130 (8-131) 100 23.7 18.5 100 NR 18.5 - Median OS, months (95% CI) (21.4-NE) (15.8-NE) Median 08, months (95% CI) (NE-NE) (15.8-NE) no - Adjusted HR (95% CI) 0.69 (0.43-1.12): 0.1328 Adjusted HR (95% CI) 0.74 (0.46-1.19); Pa 0.2122 80 so 70 70 NO GO 50 Overall : Survival % 50 Overal 40 40 ao 30 20 20 10 to 0 0 -0 - : : 0- 10 : 12 -2 -R : : is 24 -* = = : $ : : : : : 8- :- :- Months A Gennari Content of this presentation IS copyright and responsibility of the author Permission IS required for re-use 2025 ESMO congress BEHLIN Hurvitz SA or al, ESMO 2025. --- [Slide 2] Pushing beyond the 6-month PFS ceiling after CDK4/6 inhibitors Combination of SERDs/SERMs with targeted therapies including Pl3Ki and CDK4/6i represents the future of ET-based treatment in CDK4/6i-pretreated population ESR1-mut 10 ITT 9 8 7 ITT AKT-altered 6 5 4 3 2 1 0 Fulv + Imlun + Fulv + Fulv + SoC + Gired + Fulv + SoC Elac Fulv Cami75 Cami150 SoC Imlun Fulv Fulv Fulv Gedatol + Abema Capi Ipatasertib Everolimus Everolimus Gedatol Palbo EMERALD SERENA-2 EMBER-3 Capitello- 291 FINER evERA VIKTORIA-1 ESR1mut only Prior CDK4/6is (ESR1mut + wt) Prior CDK4/6is (ESR1mut + wt) Prior CDK4/6is (AKT altered+ wt) 100% previous CDK4/6is 100% previous CDK4/6is PIK3CA wt 100% previous CDK4/6is ~25% 1 CT line for ABC No CT for ABC "25% 1 CT line for ABC No prior CT for ABC 100% previous CDK4/6is 28% 1 CT line for ABC No prior CT for ABC A. Gennari Bardia A et al SBACS 2021; Bidard FC et al JCO 2022; Oliveira M et al Lancet Oncol Content of this presentation is copyright and responsibility of the author Permission is required for re-use BERLIN 2024; Jhaveri et al SABCS 2024 & NEJM 2024; Turner NC et al NEJM 2023; Chia S et 2025 ESMO congress al ASCO 2025; Mayer E et al ESMO 2025; Hurvitz S et al ESMO 2025 --- [Slide 3] Reframing the Paradigm: My Personal View Patients with HR-positive/HER2-negative MBC PD candidate for ET = targeted therapy CLINICAL PRACTICE GUIDELINES ESMO Metastatic Breast Cancer Living Guideline v1.2 April 2025 If PIK3CAmut [ESCAT I-A] / If ESR1mut [ESCAT I-A]: If germline BRCA1/2 Switch ET * CDK4/6 AKT1/PTEN alterations Elacestrant [I,A; MCBS 3]ª [ESCAT I-A] inhibitor [II, C]" [ESCAT I/II]: or PALB2mut [ESCAT Fulvestrant-capivasertib II-B]: PARP inhibitor Exemestane-everolimus HR-positive/ [I,A; MCBS 2]ab [I,A; MCBS 3-4] [1, B]* §Imlunestrant HER2-negative MBC, Fulvestrant-everolimus If PIK3CAmut [ESCAT I-A]ᶜ: Fulvestrant-alpelisib [II, Bja.b.d PD Candidate for ET + *Imlunestrant [I, B; MCBS 1]ab Fulvestrant [I, CJa,b,d Targeted Therapy + abemaciclib OFS the patient " premenopausal - not previously exposed Universit PIKELA inhibitor *Ipatasertib + *Giredestrant + *Gedatolisib + " not targeted before Preferred the patient positive and not used before fulvestrant everolimus fulvestrant + palbociclib *Giredestrant + ESR1 mutational status everolimus PD testing, if not done before *Imiunestrant + abemaciclib *Ipatasertib + Candidate for ET Not candidate for ET fulvestrant *NOT FDA approved * TT = TT $FDA approved A Gennari Content of this presentation is copyright and responsibility of the author Permission is required for re-use BERLIN 2025 ESMO congress --- [Slide 4] My conclusions when ET is the option post CDK4/6is Trials results Patients selection matters Challenges evERA and VIKTORIA trials demonstrated statistically significant Combination therapies prevent the Attrition rate in luminal MBC should and clinically meaningful outcome early KM curve decline seen in past be considered when defining early line benefit after CDK4/6is, in ITT trials and overcome the 6-month PFS tretaments analyses. barrier. Clinical judgement & shared decision A comprehensive, multitargeted Careful patient selection is key. with patients should always be approach addressing ER-related ET-based therapy should be pursued pathways has the potential to re- prioritized after CDK4/6is to maximize establish endocrine sensitivity after benefit CDK4/6 i ESMO congress BERLIN 2025

[Slide 1] 1st Co-Primary Endpoint: Progression-Free Survival Gedatolisib Triplet vs. Fulvestrant, BICR Assessment 100 Geda + Palbo Fulvestrant Fulvestrant 90 (n=131) (п=131) 80 9.3 Median PFS, months (95% CI) 2.0 (7.2-16.6) (1.8-2.3) 70 Adjusted HR (95% CI) 0.24 (0.17-0.35); P < 0.0001 Progression-free Survival (%) 60 50 40 30 20 10 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Months No. at Risk: Geda + 131 127 103 94 69 68 50 49 35 34 24 22 19 16 10 10 9 6 6 6 4 4 4 1 0 Palbo + Fulv Fulv 131 114 45 35 20 20 11 11 7 5 3 2 2 2 1 1 1 0 Presenter: Sara A. Hurvitz, MD, FACP ESMD Content of this presentation a copyrighted and responsibility of the author Permission a required for re-use

[Slide 1] 10:15 - 11:45 Proffered paper session 1: Breast cancer, metastatic CHAIRS: JAVIER CORTÉS, JANICE WING-HANG TSANG VIKTORIA-1 Study Design HR+/HER2- Arm At Advanced Breast Cancer Gedatolisib 180 mg IV once weekly 3 weeks on week off Primary Endpoints Eligibility Criteria Palbociclib 125 mg daily 21 days on days off PFS (BICR) Pre- & postmenopausal women & men Fulvestrant 500 mg: cycle days 1& 15. then Arm A vs. Arm C every weeks Arm B vs. Arm C Progression on/after CDK4/6i + NSAI STUDY 1 R 1:1:1 Arm BT <2 lines of prior ET for ABC PIK3CA-WT (N=392) Gedatolisib 180 mg IV once weekly Secondary Endpoints 3 weeks on week off Measurable disease, RECIST v1.1 Fulvestrant 500 mg; cycle 1, days 18 15. then OS Screening result for PIK3CA status every weeks Response Sara Hurvitz No T2DM with HbA1c >6.4% or T1DM Arm C Safety No prior mTORi, PI3Ki, or AKTi Assign 500 mg: cycle 1, days 1& 15, then Gedatolisib (geda) fulvestrant 1 Fulvestrant QoL every weeks palbociclib (palbo) vs fulvestrant in patients No prior chemotherapy for ABC Optional cross-over to Arm A or B at progression (pts) with HR+/ HER2-/PIK3CA wild type (WT) advanced breast cancer (ABC): First Stratification Factors Gedatolisib Palbociclib Fulvestrant results from VIKTORIA-1 Lung/liver metastases (yes/no) STUDY 2 R3:13 Gedatolisib Fulvestrant PIK3CA-MT TTP on immediate prior therapy (S or >6 months) Alpeinb Fulvestrant Region (US/Canada or ROW) Prophylactic use of steroid- containing "swish and spit regimen was protocol mandated oral non-sedating antihistamine therapy was recommended Abbreviations ABC, advanced treast cancer, AKT protein knase B inhibitor, BICR blinded independent central review CDK4/6 cycles dependent knase and elhibitor, ET. endocrine therapy HbA1c hemoglobin A1c HER2 human epidermal youth lacks receptor negative HR+ hormone receptor positive N. intravenous, MT, mutated mTOR mechanistic target rapamyon whibitor NSAI non storodal aromatase inhibitor OS, overall survival PFS progression free survival POK phosphatedyleced know Qol. quality R randomization, ROW, rest world TIOM type diabetes melitus, T2DM type diabetes melitus, TTP. time to progression WT. wild type Presenter: Sara A Hurvitz, MD. FACP ESMD Contant of his presentation copyrighted and responsibility of the author Permission is required for - BERLIN AUDITORIUM - HUB 27 --- [Slide 2] 10:15- 11:45 Proffered paper session 1: Breast cancer, metastatic CHAIRS: JAVIER CORTÉS, JANICE WING-HANG TSANG 1st Co-Primary Endpoint: Progression-Free Survival Gedatolisib Triplet vs. Fulvestrant, BICR Assessment 100 Geda Palbo + Fulvestrant Fulvestrant (n=131) 90 (n=131) 80 9.3 2.0 Median PFS, months (95% CI) (7.2-16.6) (1.8-2.3) 70 Adjusted HR (95% CI) 0.24 (0.17-0.35); P< 0.0001 Progression-free Survival (%) 60 50 40 Sara Hurvitz 30 Gedatolisib (geda) + fulvestrant t 20 palbociclib (palbo) vs fulvestrant in patients (pts) with HR+/ HER2-/PIK3CA wild-type 10- (WT) advanced breast cancer (ABC): First 0 results from VIKTORIA-1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Months No. at Risk: Geda . Palbo Fulv 131 127 103 94 69 68 50 49 35 34 24 22 19 16 10 10 9 6 6 6 4 4 4 1 0 Fulv 131 114 45 35 20 20 11 11 7 5 3 2 2 2 1 1 1 0 Presenter Sara A Hurvita, MD, FACP ESMD Content the presentation. copyrighted and responsibility of the author Permission a required for - BERLIN AUDITORIUM - HUB 27 --- [Slide 3] 10:15 - 11:45 Proffered paper session 1: Breast cancer, metastatic CHAIRS: JAVIER CORTÉS, JANICE WING-HANG TSANG PFS in Key Subgroups: Gedatolisib Triplet vs. Fulvestrant Gedatolisib Palbociclib . Fulvestrant Fulvestrant Subgroup n/N mPFS, mo. n/N mPFS, mo. Hazard Ratio (90% CI) Age <65 years 39/93 9.3 74/108 1.9 - 0.23 (0 17-0.35) 265 years 20/38 9.7 15/23 2.1 0.28 (0 16-0.55) Menopause status Pre/perimenopause 9/28 11.1 26/36 1.8 0.13 (0.07-0.29) Postmenopause 50/101 8.9 62/92 2.0 0.27 (0 19-0.38) Geographic area US/Canada 6/21 19.3 14/22 2.0 0.13 (0.05-0.36) Europe 29/57 9.3 32/48 2.0 0.17 (0 12-0.31) Latin America 16/35 5.6 20/35 3.7 0.53 (0 29-0 Asia Pacific 8/18 16.6 23/26 1.8 0.18 (0.09-0.37) Presence of visceral metastasis Yes 44/102 10.7 71/100 1.8 - 0.21 (0.16-0.30) No 15/29 8.9 18/31 5.6 0.35 (0.20-0.71) Sara Hurvitz Liver metastasis Yes 37/74 9.2 60/72 1.8 0.21 (0.14-0.30) Gedatolisib (geda) fulvestrant + No 22/57 9.9 29/59 5.4 0.31 (0.19-0.53) Lines of prior tx for ABC palbociclib (palbo) vs fulvestrant in patients y 52/115 9.7 82/118 2.0 - 0.23 (0.17-0.33) (pts) with HR+/ HER2-/PIK3CA wild type 22 7/16 5.4 7/13 1.8 0.31 (0.09-0.99) TTP on immediate prior tx (WT) advanced breast cancer (ABC): First 56 months 13/26 7.4 13/25 2.1 0.47 (0.24-0.93) results from VIKTORIA-1 >6 months 46/105 9.9 76/106 1.9 1 0.20 (0.14-0.28) Prior CDK4/6i for ABC Ribociclib 29/59 8.9 48/70 1.9 0.22 (0.14-0.34) Palbociclib 21/56 16.6 37/52 1.9 0.21 (0 13-0.35) Abemaciclib 13/23 5.4 10/16 3.1 0.31 (0.23-0.97) 0.01 0.1 1.0 10.0 Gedatolisib plus palbociclib and fulvestrant better Fulvestrant better PFS assessed by blinded independent central review Abtreviations ABC advanced breast cancer, COK4 dependent knase 4 and inhibitor, CL confidence interval, mo. months mPFS median progression free survival TTP. time to disease progression, tx therapy Presenter Sara Hurvitz, MD. FACP ESMO Contant of his presentation copyrighted and responsibility the author Permission required for - BERLIN AUDITORIUM - HUB 27 --- [Slide 4] 10:15 11:45 Proffered paper session 1: Breast cancer, metastatic CHAIRS: JAVIER CORTÉS, JANICE WING-HANG TSANG Safety and Tolerability Treatment-Related Adverse Events (Safety Population)* SAE and Gedatolisib + palbociclib fulvestrant Gedatolisib fulvestrant Fulvestrant discontinuation, (n=130) (n=130) (n=123) (%) Pts with a1 SAE 14 (10.8) 12(9.2) 1 (0.8) Study treatment D/C due to TRAE 3(2.3) 4(3.1) 0 Deaths due to TRAET 2(1.5) 0 0 Gedatolisib palbociclib fulvestrant Gedatolisib fulvestrant Fulvestrant Adverse events, (n=130) (n=130) (n=123) n (%) Any Grade Grade 3 Grade 4 Any Grade Grade 3 Grade 4 Any Grade Grade 3 Grade 4 Sara Hurvitz Stomatitis 90 (69.2) 25 (19.2) 0 74 (56.9) 16 (12.3) 0 0 0 0 Gedatolisib (geda) + fulvestrant t Neutropenia 85 (65.4) 68 (52.3) 13 (10.0) 2(1.5) 0 1 (0.8) 1 (0.8) 1 (0.8) 0 palbociclib (palbo) vs fulvestrant in patients Nausea 57 (43.8) 5(3.8) 0 56 (43.1) 1 (0.8) 0 4(3.3) 0 0 (pts) with HR+/ HER2-/PIK3CA wild type Rash 36 (27.7) 6(4.6) 0 42 (32.3) 7 (5.4) 0 0 0 0 (WT) advanced breast cancer (ABC): First Vomiting 36 (27.7) 2(1.5) 0 30 (23.1) 0 0 1 (0.8) 0 0 results from VIKTORIA-1 Fatigue 29 (22.3) 2(1.5) 0 27 (20.8) 1 (0.8) 0 5(4.1) 0 0 Diarrhea 22 (16.9) 2(1.5) 0 16 (12.3) 1 (0.8) 0 0 0 0 Hyperglycemia24 12 (9.2) 3 (2.3) 0 15 (11.5) 3 (2.3) 0 0 0 0 Abbreviations D/C discontinued Pts. patients SAE serious adverse event TRAE treatment-related related adverse event per investigator) "Shown are adverse events of any grade that occurred in least 20% the patients any trial group unless otherwise noted *Grade events include one considered related to palbocicle (prisumonia) and one due to hepatic failure patient with multiple liver considered related to all three drugs (and likely associated with disease) For stomatis, neutroponia, rash and ryperglycemia, combined preferred terms shown patient experienced multiple terms, was counted once for the highest grade Additional events of clinical importance Presenter: Sara A. Hurvitz, MD, FACP ESMD Contant this presentation is copyrighted and responsibility of he author Permission required BERLIN AUDITORIUM - HUB 27