4MO Updated results for MK-1084 + pembrolizumab in KRAS G12C-mutated (mut) metastatic non-small cell lung cancer (mNSCLC) enrolled in KANDLELIT-001

ParametersGotistobart N45 Docetaxel N42Confirmed ORR by investigator, n (%) [95% CI] 9 (20.0)[9.6, 34.6] 2 (4.8) [0.6, 16.2] Median DoR by investigator, m (95% CI) 11.0 (3.5, NE) 3.8 (3.5, NE) Median PFS by investigator, m (95% CI) 2.4 (2.1, 4.5) 2.6 (2.1, 3.9) PFS rate at 6 m, % (95% CI) 32.7 (19.1, 47.1) 12.9 (4.2, 26.7) PFS rate at 12 m, % (95% CI) 25.2 (13.2, 39.2) 0 PFS HR (95% CI) 0.69 (0.42, 1.13) Median OS, m (95% CI) NE (9.3, NE) 10.0 (6.2, 11.9) OS rate at 12 m, % (95% CI) 63.1 (46.9, 75.5) 30.3 (16.2, 45.6) OS HR (95% CI) 0.46 (0.25, 0.84) Conclusions: Gotistobart monotherapy, offering a chemotherapy-free option, demonstrated durable anti-tumor activity with clinically meaningful survival benefit compared to docetaxel in sqNSCLC after progression on anti-PD-(L)1 therapy, addressing a critical unmet need for effective treatments in this population.The pivotal Stage 2 part is enrolling patients with sqNSCLC globally.

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Journal
ESMO Open
Published
2026-03-17
DOI
https://doi.org/10.1016/j.esmoop.2026.106311
Primary Topic
Cancer Immunotherapy and Biomarkers
Type
article
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article

4MO Updated results for MK-1084 + pembrolizumab in KRAS G12C-mutated (mut) metastatic non-small cell lung cancer (mNSCLC) enrolled in KANDLELIT-001

Thomas Jemielita, L. Rhoda Molife, Matteo Simonelli, I. Ruíz-Gutiérrez et al.
ESMO Open
Cancer Immunotherapy and Biomarkers
article

4MO Updated results for MK-1084 + pembrolizumab in KRAS G12C-mutated (mut) metastatic non-small cell lung cancer (mNSCLC) enrolled in KANDLELIT-001

Thomas Jemielita, L. Rhoda Molife, Matteo Simonelli, I. Ruíz-Gutiérrez, Y-L. Su, Maya Gottfried, Yakir Rottenberg, A.G. Sacher, C.I. Rojas, M.A.N. Sendur, S.Y. Choi, G. Ursol, L. Liu, I. Lugowska, C-C. Lin, J. Bar, O. Kobziev, M. Kwiatkowski, T. Yoshida, A. Raskov Kodahl
article en

Abstract

ParametersGotistobart N45 Docetaxel N42Confirmed ORR by investigator, n (%) [95% CI] 9 (20.0)[9.6, 34.6] 2 (4.8) [0.6, 16.2] Median DoR by investigator, m (95% CI) 11.0 (3.5, NE) 3.8 (3.5, NE) Median PFS by investigator, m (95% CI) 2.4 (2.1, 4.5) 2.6 (2.1, 3.9) PFS rate at 6 m, % (95% CI) 32.7 (19.1, 47.1) 12.9 (4.2, 26.7) PFS rate at 12 m, % (95% CI) 25.2 (13.2, 39.2) 0 PFS HR (95% CI) 0.69 (0.42, 1.13) Median OS, m (95% CI) NE (9.3, NE) 10.0 (6.2, 11.9) OS rate at 12 m, % (95% CI) 63.1 (46.9, 75.5) 30.3 (16.2, 45.6) OS HR (95% CI) 0.46 (0.25, 0.84) Conclusions: Gotistobart monotherapy, offering a chemotherapy-free option, demonstrated durable anti-tumor activity with clinically meaningful survival benefit compared to docetaxel in sqNSCLC after progression on anti-PD-(L)1 therapy, addressing a critical unmet need for effective treatments in this population.The pivotal Stage 2 part is enrolling patients with sqNSCLC globally.

ESMO OpenVol. 11
Merck & Co., Inc., Rahway, NJ, USA (United States) (US), Humanitas University (IT), Sheba Medical Center (IL), Hadassah Medical Center (IL), Odense University Hospital (DK), Meir Medical Center (IL), Princess Margaret Cancer Centre (CA), MSD (UK) Limited (United Kingdom) (GB), National Cancer Centre Japan (JP), National Cancer Center (US), Kaohsiung Chang Gung Memorial Hospital (TW), Nanfang Hospital (CN), Finis Terrae University (CL), Rivne State University of Humanities (UA), National Taiwan University Hospital (TW), Clinica Universidad de Navarra (ES), Centrum Onkologii (PL), National Cancer Center Hospital East (JP), Ankara Yıldırım Beyazıt University (TR), State Higher Vocational School in Koszalin (PL), Southern Medical University (CN)
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