KOL Pulse — Trial Profile

KANDLELIT-001 Trial

Advanced KRAS G12C-mutant solid tumors (CRC and NSCLC) — Merck & Co. (MK-1084, KRAS G12C inhibitor)

Advanced KRAS G12C-mutant solid tumors (CRC and NSCLC)ASCO 2025
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Top KOLs Discussing KANDLELIT-001

LARVOL
LARVOL
@Larvol
2.8K impressions
Hidehito HORINOUCHI
Hidehito HORINOUCHI
@HHorinouchi
1.3K impressions
Bartomeu Massuti
Bartomeu Massuti
@bmassutis
1.1K impressions
Dr Amol Akhade
Dr Amol Akhade
@SuyogCancer
1.1K impressions
Bhaarath PG
Bhaarath PG
@BhaarathP10039
805 impressions
VJ Oncology
VJ Oncology
@VJOncology
146 impressions

KANDLELIT-001 Key Slides & Visuals

Official trial slides and relevant visuals shared by KOLs at ASCO 2025. Click any image to expand.

Hidehito HORINOUCHI
Hidehito HORINOUCHI @HHorinouchi
KANDLELIT-001 Data
1.3K impressions · 10 likes · Mar 26, 2026
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[Slide 1] ongoing open-label, phase 1 study of calderasib as monotherapy NSCLC) or as KANDLELIT-001: part of combination An therapy (arms with KRAS G12C-mutated metastatic Arms 1+ 3 (N=193 all solid tumors; n=68 NSCLC): Calderasib Monotherapy 25-800 mg/d POª Locally advanced unresectable or metastatic solid tumor 21 prior systemic therapy for advanced disease Key Eligibility Criteria (all arms) Age ≥ 18 years Arm 2 (N=107): Calderasib 25-400 mg/d POª + Pembrolizumabᵇ Histologic or blood-based confirmation of Metastatic NSCLC with PD-L1 TPS ≥1% KRAS G12C mutation No indication for EGFR-, ALK-, or ROS1-directed therapy as primary treatment ECOG PS 0 or 1 No prior therapy for metastatic disease Measurable disease per RECIST v1.1 Arm 4 (N=46): Calderasib 25-400 mg/d POª + Pembrolizumab + Chemotherapy© Metastatic NSCLC with any TPS No indication for EGFR-, ALK-, or ROS1-directed therapy as primary treatment No prior therapy for metastatic disease Primary endpoint: Incidence of DLTs, AEs, and AEs that led to discontinuation Secondary endpoints: ORR and DOR per RECIST v1.1 by investigator assessment; pharmacokinetic measures of calderasib administered as monotherapy or as part of combination therapy 500 ng/ N Q3W carboplatin PDL1 area under the concentration-time curve 5 mg/mL/min administered IV cycles. Chemotherapy Cabbrash POQD or BD for the total daily dose indicated Pembrolizumab 200mg IV Q3W for <35 lesting was not required for enrollment but archival or fresh tumor samples Q3W was for submitted 4 cycles and for pemetrexed each participant Organisers Partners ESMO IASLC INTERNATIONAL ASSOCIATION FOR THE ESTRO I or LUNG I 1 ETOP-IBCSG foundwink lings Hereby I --- [Slide 2] Best change from baseline in target lesion sizeᵃ Total (N=98) TPS 1%-49% (n=44) TPS >50% (n=54) Arms 2: Calderasib + Pembro (TPS >1%) 100 72 (63-81) 55 (39-70) 87 (75-95) ORR % (95% CI) 80 Median TTR (range), months 1.4 (1.2-10.3) 1.4 (1.2-4.2) 1.4 (1.2-10.3) 60 Median DOR (range), months NR (1.4+ to 37.1+) NR (1.4+ to 37.1+) 27.8 (1.5+ to 30.6+) 40 DCR, % (95% CI) 95 (88-98) 93 (81-99) 96 (87-100) 100 Arms 1+3 Calderasib Monotherapy NSCLC Only (N-59) ORR %(95% C) 27 (16-40) Best Change From Baseline in Target Lesion Size, % 20 0 -20 80 Median TTR (range). months 40 60 14(1226) Median DOR (tange) months 23(12+ to 30.6+) -60 40 I I From & li I 40 20 DOR %(%%C) 20 71 (58-82) -80 0 -100 100 Arm 4: Calderasib + Pembro + Chemo Total (N=46) & 80 ORR % (95% CI) 65 (50-79) 80 60 Median TTR (range), months 100 1.5 (1.2-18.1) 40 Median DOR (range), months Best Change From Baseline in Target Lesion Size, % DCR, % (95% CI) NR (1.9+ to 21.1+) 20 89 (76-96) 0 DCR and By who investigabor disease were first review dosed per at RECIST least / weeks v1 1, includes before the all date participants with at postbaseline maging assessment -20 40 DCO TTR date time 05JAN2026 b response control rate DOR duration of response; NR of not data reached, culoff ORR objective response rate; -60 -80 -100 --- [Slide 3] Progression-free survivalᵃ Participants in arm 2 by PD-L1 TPS Participants with NSCLC (arms 1+ 3,2, and 4) 100 12-mo rate 100 12-mo rate 81% 75% 90 90 66% 54% 80 41% 80 / I / 20 30 70 60- Progression-free survival, % 70 60 50 50 40 40 30 6-mo rate 90% 20 10- 82% 6-mo rate 60% 10 0 94% 0 $ 84% 10 15 20 25 30 0 35 40 No. at ml 45 Time (months) 0 5 10 15 Am2 N 20 25 75 $5 30 43 35 Amt - 23 37 14 $ No. risk 40 45 28 12 2 3 0 INSCLC Time (months) . - 0 0 1 0 TPS >50% 54 I 7 0 45 5 2 0 38 0 TPS 1%-49% 44 29 1 32 16 17 10 0 0 2 14 7 0 0 4 3 0 2 0 0 Am 2 Calderasib + pembro YL NSCLC with TPS 21%) Pts With Event Median PFS (95% CI) Am Calderasib + pembro chemo (12 NSCLC: any TPS) 29/98(30%) 28.9(20.6-NR) Arms 1+ Calderasib monotherapy (advanced NSCLC) 19/46(41%) Arm 2 Calderasib + pembro (1L NSCLC with TPS >50%) Pts With Event 15.1(10.5-NR) Median PFS (95% CI) 22/59(37%) 8.3(4.2-18.1) Arm 2 Calderasib + pembro (1L NSCLC with TPS 1%-49%) 15/54 (28%) NR (20.6-NR) 14/44 (32%) 25.1 (9.5-NR) DOO By investigator date 05JAN2026 review per RECIST 1 1, includes participants who were first dosed at least / weeks before the date of data cutoff Organisers ESMO ASLC Partners INTERNATIONAL ASSOCIATION OF LUNG ESTRO I / ETOP-IBCSG --- [Slide 4] Summary of treatment-related adverse events (TRAEs) Arms 3 Arm 2 Arm 4 N=107 N=46 N=193 Arm 4 TRAEs in the safety population* 117 (61) 95 (89) 45 (98) 125 Am 2 Arms w Calderasib . Pembro Chemo Any grade TRAE, n (%) Calderasib Calderasib Pembro IL NSCLC; any TPS 16 (8) 30 (28) 25 (54) 97% Monotherapy 12 NSCLC with TPS 21% №46 Grade 3 1 (<1) 4 (4) 4 (9) AT Sold Tumors №107 Grade 4 30% N-193 0 1 (1)b 1 (2)c Grade 5 Gr12 # $ Q12 G12# G:35 . Led to discontinuation of calderasib 1 (<1) (5) 3(7) Q35 # G35 . 60% Arms 3 Arm 2 Arm 4 / , 50% 48 43 43 DLTs in the DLT-evaluable population N=183 N=102 N=46 39 37 4% 36 35 Any DLT, (%) 2(1) 2(2) 5 (11) 34 32 30 ALT increased (grade 3) 0 1(1) 2 (4) 30% 24 24 22 AST increased (grade 3) 0 1(1) 1 (2)e 20 20 20% 17 17 15 15 15 Blood alkaline phosphate increased 1 (<1) 0 0 12 12 12 11 11 11 11 13 13 13 13 12% Colitis (grade 3) 0 0 (2) Diarrhea (grade 3) 0 0 a 1 (2) AST y is AST ALTT Rash in FORTALPT Anemia 1st HUNDO A 3BM Pruntus Creatine Page GGT ECG QT prolonged (grade 3) 1 (<1) 0 0 Nausea (grade 3) 0 0 1 (2) Immune-mediated nephritis (grade 3) 0 1 (1) 0 tholudes all participants who received 21 dose of study treatment One participant experienced grade 5 myelosuppression and 5 cohors platelet who count decreased One participant experienced grade 5 immune-mediated myositis includes all participants in dose escalation grade Numbers 2 and one participant in am 4 experienced grade 3 increases in both ALT and AST participant in received am 21 dose of study treatment and ether completed cycle 1 without a DLT or experienced a DLT in cycle 1. "One ALP, alkaine in the bar charts represent the total incidence of grade events for TRAEs with incidence DCO date 05JAN2026 phosphatase; ALT, alanine transaminase, AST, aspartate aminotransferase; GGT, gamma-glutamyltransferase >10% Organisers Partners ESMO IASLC INTERNATIONAL FOR THE or LUNG ESTRO I I ETOP-IBCSG /
LARVOL
LARVOL @Larvol
KANDLELIT-001 Data
2.8K impressions · 16 likes · Mar 28, 2026
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Bartomeu Massuti
Bartomeu Massuti @bmassutis
KANDLELIT-001 Data
1.1K impressions · 9 likes · Mar 26, 2026
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Dr Amol Akhade
Dr Amol Akhade @SuyogCancer
KANDLELIT-001 Data
1.1K impressions · 3 likes · May 23, 2025
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VJ Oncology
VJ Oncology @VJOncology
KANDLELIT-001 Data
146 impressions · 1 likes · Mar 27, 2026
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KANDLELIT-001 Top Tweets

Top tweets by impressions — click to view on X

LARVOL
LARVOL@Larvol

Updated KANDLELIT-001 data from ELCC 2026 in 1L KRAS G12C Adv/m NSCLC landscape from Dr. Jordi Remon (@JordiRemon) 👉 https://t.co/HArEDy2BpZ

Updated Landscape ⬇️: https://t.co/TBeOl7P9qH

Explore…

👁 2.8K ♡ 16 ↻ 9 Mar 28, 2026
Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🆙 #ELCC26 @myESMO @IASLC 🇩🇰
🔥Mini Oral session 1
☑️KANDLELIT-001: MK-1084 + Pembrolizumab in KRAS G12C
🎯Tx Naive mNSCLC (PD-L1 ≥50%): ORR 87%
🎙️Dr. Adrian G. Sacher
🎙️Chair: @DocSacher Dr. Andreas…

👁 1.3K ♡ 10 ↻ 5 Mar 26, 2026
Bartomeu Massuti
Bartomeu Massuti@bmassutis

MK1084 + Pembrolizumab in NSCLC with KRAS mut+ G12C at #ELCC2026 @OncoAlert https://t.co/zbc8OY7pRD

👁 1.1K ♡ 9 ↻ 4 Mar 26, 2026
Dr Amol Akhade
Dr Amol Akhade@SuyogCancer

Full abstract for the data below 🙂👇 @GIMedOnc @NiuSanford @ASCO #ASCO25 https://t.co/TXrsJbMw8e https://t.co/6QktY7TxQv

👁 1.1K ♡ 3 ↻ 0 May 23, 2025
Bhaarath PG
Bhaarath PG@BhaarathP10039

Top Trials to Follow on Day 2 @myESMO #ELCC26
KANDLELIT-001 | ADEPPT | NORTHSTAR | ASTEROID | BeamionLung-1 | BECOME
#ELCC #ELCC2026 #Cancer #Oncology #LungCancer #NSCLC #SCLC #lcsm #pembrolizumab

👁 560 ♡ 2 ↻ 0 Mar 25, 2026
Bhaarath PG
Bhaarath PG@BhaarathP10039

@myESMO #ELCC26: Top Trials from Day 2
ADEPPT | BeamionLung-1 | ASTEROID | NORTHSTAR | BECOME | KANDLELIT-001 | NCT02941458
#ELCC #ELCC2026 #Cancer #Oncology #LungCancer #NSCLC #SCLC #lcsm

👁 245 ♡ 2 ↻ 0 Mar 26, 2026
VJ Oncology
VJ Oncology@VJOncology

From KANDLELIT-001 to Beamion LUNG-1 to BECOME, Adrian Sacher (@DocSacher) breaks down the latest data shaping HER2-mutant and exon 20 NSCLC at #ELCC26

Full interview coming soon to…

👁 146 ♡ 1 ↻ 0 Mar 27, 2026
Lung Cancers Today
Lung Cancers Today@Lung_Cancers

🫁 Up next at #ELCC26: The first mini oral abstract session, chaired by @DocSacher of @pmcancercentre, @uoftmedicine, @UofT and Dr. Andreas Rimner of Universitätsklinikum Freiburg, begins at 16:00 CET…

👁 137 ♡ 4 ↻ 3 Mar 26, 2026

About the KANDLELIT-001 Trial

KANDLELIT-001 is Merck's entry into the KRAS G12C inhibitor space with MK-1084. Phase 1 showed competitive CRC response rates (confirmed ORR 38-46%) across monotherapy and combinations with cetuximab ± mFOLFOX6. Phase 3 KANDLELIT-012 (1L KRAS G12C mCRC combo vs. SOC) and KANDLELIT-004 (1L KRAS G12C NSCLC + PD-L1 TPS≥50% + KEYTRUDA) are the registrational paths. Competes with sotorasib (Lumakras approved in KRAS G12C CRC via CodeBreaK 300) and adagrasib (Krazati, KRYSTAL-10/12). KRAS G12C space is increasingly crowded — MK-1084's Phase 3 data will determine its commercial positioning.

Trial Methodology & Results

Overall Response Rate (ORR), Safety, Dose Optimization — Phase 1 Open-Label

CRC: MK-1084 monotherapy (N=53, previously treated) rate: 38% (confirmed ORR) vs. 43% (unconfirmed ORR). CRC: MK-1084 + cetuximab (N=39) rate: 46% (confirmed ORR) vs. 56% (unconfirmed ORR). CRC: MK-1084 + cetuximab + mFOLFOX6 (N=29) rate: 38% (confirmed ORR) vs. 66% (unconfirmed ORR). Phase 1 open-label KANDLELIT-001 study of MK-1084 (Merck's KRAS G12C inhibitor) alone and in combinations in KRAS G12C-mutant advanced solid tumors (CRC, NSCLC). In CRC (previously treated): MK-1084 monotherapy (N=53) confirmed ORR 38% / unconfirmed 43%; MK-1084 + cetuximab (N=39) confirmed ORR 46% / unconfirmed 56%; MK-1084 + cetuximab + mFOLFOX6 (N=29) confirmed ORR 38% / unconfirmed 66%. In NSCLC: antitumor activity demonstrated; specific rates not detailed in press release. Manageable safety profile across all arms. Data support advancing to Phase 3: KANDLELIT-012 (1L combo in mCRC) and KANDLELIT-004 (1L KRAS G12C + PD-L1 TPS≥50% + pembrolizumab in NSCLC).

✓ CRC confirmed ORR: 38% mono / 46% + cetux / 38% + cetux+chemo

📄 Source: KOL commentary on X →

Overall Survival (OS)

Phase 1 — mature PFS/OS not reported. Phase 3 trials (KANDLELIT-012, KANDLELIT-004) will test survival endpoints.


📄 Source →

Safety & Tolerability

Manageable safety profile across monotherapy and combinations per Merck press release. Specific AE rates not detailed in available sources.

✓ Manageable safety profile

📄 Source →

Clinical Implications

🔬 Early-phase signal supports Phase 3 development of MK-1084 in KRAS G12C CRC and NSCLC. KANDLELIT-001 is Merck's entry into the KRAS G12C inhibitor space with MK-1084. Phase 1 showed competitive CRC response rates (confirmed ORR 38-46%) across monotherapy and combinations with cetuximab ± mFOLFOX6. Phase 3 KANDLELIT-012 (1L KRAS G12C mCRC combo vs. SOC) and KANDLELIT-004 (1L KRAS G12C NSCLC + PD-L1 TPS≥50% + KEYTRUDA) are the registrational paths. Competes with sotorasib (Lumakras approved in KRAS G12C CRC via CodeBreaK 300) and adagrasib (Krazati, KRYSTAL-10/12). KRAS G12C space is increasingly crowded — MK-1084's Phase 3 data will determine its commercial positioning.

KANDLELIT-001 in the News

Key KOL Sentiments — KANDLELIT-001

DoctorSentimentComment
LARVOL ● NEUTRAL Updated KANDLELIT-001 data from ELCC 2026 in 1L KRAS G12C Adv/m NSCLC landscape from Dr. Jordi Remon (@JordiRemon) 👉 https://t.co/HArEDy2BpZ Updated Landscape ⬇️: https://t.co/TBeOl7P9qH Explore more insights and conference data from #ELCC26 👉 https://t.co/AOHoQjZywG #LARVOL https://t.co/xtFIEMDCIn
Hidehito HORINOUCHI ● NEUTRAL 🆙 #ELCC26 @myESMO @IASLC 🇩🇰 🔥Mini Oral session 1 ☑️KANDLELIT-001: MK-1084 + Pembrolizumab in KRAS G12C 🎯Tx Naive mNSCLC (PD-L1 ≥50%): ORR 87% 🎙️Dr. Adrian G. Sacher 🎙️Chair: @DocSacher Dr. Andreas Rimner 📍NCT05067283 @OncoAlert @Larvol @KRASKickers #LCSM https://t.co/fkJQVt0boS https://t.co/TCV4V3bodH
Bartomeu Massuti ● NEUTRAL MK1084 + Pembrolizumab in NSCLC with KRAS mut+ G12C at #ELCC2026 @OncoAlert https://t.co/zbc8OY7pRD
Dr Amol Akhade ● NEUTRAL Full abstract for the data below 🙂👇 @GIMedOnc @NiuSanford @ASCO #ASCO25 https://t.co/TXrsJbMw8e https://t.co/6QktY7TxQv
Bhaarath PG ● NEUTRAL Top Trials to Follow on Day 2 @myESMO #ELCC26 KANDLELIT-001 | ADEPPT | NORTHSTAR | ASTEROID | BeamionLung-1 | BECOME #ELCC #ELCC2026 #Cancer #Oncology #LungCancer #NSCLC #SCLC #lcsm #pembrolizumab #adagrasib #durvalumab #zongertinib #becotarug #osimertinib #EGFR #KRAS #ERBB2 https://t.co/YorVHdKNyu
Bhaarath PG ● NEUTRAL @myESMO #ELCC26: Top Trials from Day 2 ADEPPT | BeamionLung-1 | ASTEROID | NORTHSTAR | BECOME | KANDLELIT-001 | NCT02941458 #ELCC #ELCC2026 #Cancer #Oncology #LungCancer #NSCLC #SCLC #lcsm #ClinicalTrials #OncologyEvents #CancerResearch #OncTwitter #MedTwitter #MedX #LARVOL https://t.co/kXpp9llxGO
VJ Oncology ● NEUTRAL From KANDLELIT-001 to Beamion LUNG-1 to BECOME, Adrian Sacher (@DocSacher) breaks down the latest data shaping HER2-mutant and exon 20 NSCLC at #ELCC26 Full interview coming soon to https://t.co/ys1d8pDAKO... @myESMO #NSCLC #LungCancer #LCsm https://t.co/SBz5ZML2n5
Lung Cancers Today ● NEUTRAL 🫁 Up next at #ELCC26: The first mini oral abstract session, chaired by @DocSacher of @pmcancercentre, @uoftmedicine, @UofT and Dr. Andreas Rimner of Universitätsklinikum Freiburg, begins at 16:00 CET with KANDLELIT-001! ➡️ Stay tuned for coverage: https://t.co/T4s6U96bT2 https://t.co/W53CFtgxUe