Elisrasib monotherapy demonstrates notable efficacy in three major tumor types at its recommended phase 2 dose (RP2D, 600 mg once a day). Phase 2 clinical results include:
- KRAS G12Ci 2L+ naive NSCLC: ORR 58.8%, mPFS 12.2 months
- Colorectal cancer (CRC) 2L+: ORR 46.9%, mPFS 9.5 months
- Pancreatic Ductal Adenocarcinoma (PDAC) 2L+: ORR 65.0%, mPFS 13.5 months
Additionally, significant efficacy was observed in KRAS G12C inhibitor-pretreated and refractory NSCLC, with an ORR of 32.3% and mPFS of 8.1 months, and significant activity in patients with CNS metastases.
SHANGHAI, April 30, 2026 /PRNewswire/ — D3 Bio Inc., a global clinical-stage biotechnology company dedicated to developing innovative oncology treatments, today announced new Phase 2 clinical data from its lead asset, elisrasib (D3S-001), a next-generation KRAS G12C inhibitor, as well as additional clinical and preclinical results from its KRAS-focused pipeline. Phase 2 studies demonstrate that elisrasib exerts broad antitumor activity against several KRAS G12C mutant solid tumors, including NSCLC, CRC, and PDAC.
Phase 2 data on elisrasib was shared as oral presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, Clinical Plenary Session (Abstract CT020), and Clinical Trials Mini-Symposium (Abstract CT303) in San Diego, California.
Extensive and durable clinical activity observed in all indications
In KRAS G12Ci 2L+ naïve NSCLC (n=68), elisrasib demonstrated robust efficacy at RP2D (600 mg once daily) with an ORR of 58.8%, median duration of response (mDoR) of 16.5 months, and mPFS of 12.2 months. Among late-line NSCLC patients refractory to prior KRAS G12C inhibitor therapy (n=31), an ORR of 32.3%, mDoR of 15.6 months, and mPFS of 8.1 months were recorded. In previously treated CRC, elisrasib showed significant efficacy both as monotherapy (n = 32, ORR 46.9%, mDoR 13.1 months and mPFS 9.5 months) and in combination with cetuximab (n = 29, ORR 62.1%, mDoR 7.0 months and mPFS 8.2 months). Further studies are planned to evaluate optimized combination strategies to improve response durability in CRC. For last-line PDAC, monotherapy (n=20) achieved an ORR of 65.0%, mDoR of 10.8 months, and mPFS of 13.5 months.
Favorable security profile
Elisrasib was well tolerated in NSCLC, CRC, and PDAC populations. Treatment-related adverse events (TEAEs) grade 3 or higher ranged from 8.7% to 15.6% in these indications. Combination treatment with cetuximab was associated with a higher incidence of grade 3 TREs, which were manageable and largely attributed to cetuximab. A single event of transient, asymptomatic grade 4 hypokalemia was reported, with no additional grade 4 or 5 TRAEs observed.
Expert commentary
“Elisrasib demonstrates the ability to provide deeper and more durable tumor responses, even in cases where first generation KRAS G12C inhibitors have failed. Overall, these results indicate that elisrasib can significantly improve the treatment of lung cancer patients with KRAS G12C mutations,” said Professor Byoung Chul Cho, MD, PhD, Yonsei Cancer Center, Yonsei University College of Medicine, Korea, and principal investigator of the study. “Among patients whose disease progressed with first-generation inhibitors, we found five cases of KRAS gene amplification, an important mechanism for evading the effectiveness of the KRAS G12C inhibitor. Of these five KRAS amplification cases, four showed tumor shrinkage, three showed clinical response, and the disease control rate was 100%, indicating the effectiveness of elisrasib in this biomarker-defined group.
Additional D3 Bio Presentations at AACR 2026
D3 Bio also presented the progress of its KRAS program, including:
- First-in-human Phase 1 Study of D3S-002, a Selective ERK1/2 Inhibitor, in Advanced Solid Tumors With MAPK Pathway Mutations — Poster (Abstract CT060)
- Clinical Pharmacokinetic Modeling of D3S-003, an Oral Dual-State KRAS G12D Inhibitor—Poster (Abstract 1831)
- D3S-003: An allele-specific, orally available KRAS G12D (OFF/ON) inhibitor with best-in-class potential – Poster (Abstract 4569)
“We are encouraged by the consistent and robust clinical activity exhibited by elisrasib in various KRAS G12C mutant tumors, reinforcing the strength and momentum of D3 Bio’s expanding KRAS pipeline,” commented Dr. George Chen, Founder, Chairman and CEO of D3 Bio. “These data suggest that elisrasib could become a foundational treatment for KRAS G12C mutant cancers.”
About elisrasib (D3S-001)
Elisrasib is a next-generation KRAS G12C inhibitor designed for rapid, comprehensive, and selective target engagement. It covalently binds to the GDP-bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, full engagement of KRAS G12C at clinically relevant exposures, and CNS penetration capability. Elisrasib is currently being evaluated globally in a Phase 2 monotherapy and combination trial in KRAS G12C mutant solid tumors, including NSCLC, CRC and others.
Key publications:
Discovery of cancer
Natural medicine (2025) 31(8):2768-2777
About the D3S-002
D3S‑002 is a selective ERK1/2 inhibitor specifically designed for combination approaches, providing vertical inhibition of the MAPK pathway to improve efficacy and overcome acquired resistance, particularly in tumors previously treated with KRAS G12C inhibitors.
Key publication:
Cancer Res April 1 2023; 83 (7_Supplement): 5501.
About the D3S-003
D3S‑003 is a differentiated KRAS G12D inhibitor targeting both active (ON) and inactive (OFF) conformations, addressing one of the most common KRAS mutations. This program expands D3 Bio’s KRAS multi-allele portfolio, aiming to provide innovative therapies for various malignancies caused by KRAS.
About D3 Bio
D3 Bio is a global biotechnology company focused on the discovery, development and registration of novel oncology and immunology therapies with first- or next-level potential. Guided by deep clinical knowledge and biomarker-driven strategies, the Company is advancing a portfolio of programs targeting key oncogenic drivers and immune pathways. D3 Bio holds worldwide rights to all of its programs.
For more information, please visit www.d3bio.com
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