Advanced KRAS G12C-mutant solid tumors (CRC and NSCLC) — Merck & Co. (MK-1084, KRAS G12C inhibitor)
Discover KOL Sentiment on KANDLELIT-001 →Design - Phase 1 open-label first-in-human trial of MK-1084 (proposed INN calderasib, oral KRAS G12C inhibitor) +/- cetuximab +/- mFOLFOX6 in advanced KRAS G12C-mutant solid tumors (CRC and NSCLC) (NCT05067283; Merck).
CRC response (Phase 1) - Confirmed ORR 38% (monotherapy, N=53, previously treated), 46% (MK-1084 + cetuximab, N=39), and 38% (MK-1084 + cetuximab + mFOLFOX6, N=29).
Survival - Phase 1 - mature progression-free and overall survival not reported; Phase 3 trials (KANDLELIT-012, KANDLELIT-004) will test survival endpoints.
Safety - Manageable safety profile across monotherapy and combinations per Merck; specific adverse-event rates not detailed in available sources.
Development - Early-phase signal supports Phase 3 development in KRAS G12C colorectal cancer (KANDLELIT-012, first-line combination) and NSCLC (KANDLELIT-004, with pembrolizumab).
Regulatory / sponsor - Investigational; not FDA approved. Merck & Co. (MK-1084 / calderasib).
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated July 21, 2026.
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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…
🆙 #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…
MK1084 + Pembrolizumab in NSCLC with KRAS mut+ G12C at #ELCC2026 @OncoAlert https://t.co/zbc8OY7pRD
Full abstract for the data below 🙂👇 @GIMedOnc @NiuSanford @ASCO #ASCO25 https://t.co/TXrsJbMw8e https://t.co/6QktY7TxQv
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…
@myESMO #ELCC26: Top Trials from Day 2
ADEPPT | BeamionLung-1 | ASTEROID | NORTHSTAR | BECOME | KANDLELIT-001 | NCT02941458
#ELCC #ELCC2026 #Cancer #Oncology #LungCancer #NSCLC #SCLC #lcsm…
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
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🫁 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…
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.
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).
Phase 1 — mature PFS/OS not reported. Phase 3 trials (KANDLELIT-012, KANDLELIT-004) will test survival endpoints.
Manageable safety profile across monotherapy and combinations per Merck press release. Specific AE rates not detailed in available sources.
🔬 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 (NCT05067283) is a Phase 1, open-label, first-in-human trial from Merck evaluating MK-1084 (proposed INN calderasib), an oral KRAS G12C inhibitor, alone and in combination with cetuximab and/or mFOLFOX6 chemotherapy, in patients with advanced KRAS G12C-mutant solid tumors including colorectal cancer and non-small cell lung cancer.
In colorectal cancer, MK-1084 produced confirmed objective response rates of 38% as monotherapy (N=53, previously treated), 46% in combination with cetuximab (N=39), and 38% with cetuximab plus mFOLFOX6 (N=29). These are competitive Phase 1 response rates; mature progression-free and overall survival were not reported at this early stage.
No. MK-1084 (proposed INN calderasib) is an investigational oral KRAS G12C inhibitor and is not FDA-approved. KANDLELIT-001 is a Phase 1 first-in-human study; Phase 3 trials (KANDLELIT-012 in first-line metastatic colorectal cancer and KANDLELIT-004 in NSCLC with pembrolizumab) are planned or underway to test survival endpoints.
Merck described a manageable safety profile across monotherapy and combination cohorts. Specific adverse-event rates were not detailed in the available sources at the time of the Phase 1 presentation; further characterization is expected as the program advances into Phase 3.
KANDLELIT-001 is Merck's entry into the KRAS G12C inhibitor space with MK-1084 (calderasib). The Phase 1 colorectal-cancer response rates of 38-46% across monotherapy and cetuximab-based combinations support Phase 3 development in KRAS G12C colorectal cancer and NSCLC, an area of active competition among KRAS G12C-targeted therapies.