#USA #San Diego #KRAS G12C #D3 Bio #elisrasib

D3 Bio's Latest KRAS Pipeline Updates at AACR 2026

On April 29, 2026, D3 Bio Inc., a pioneering biotechnology company, presented significant updates regarding its KRAS inhibitor, Elisrasib (D3S-001), at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA. This next-generation KRAS G12C inhibitor has shown promising efficacy across multiple tumor types in phase 2 clinical trials, particularly in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).

Phase 2 Clinical Outcomes

Elisrasib demonstrated remarkable single-agent efficacy in various tumor types at its recommended phase 2 dose (RP2D) of 600 mg administered once daily. Key clinical outcomes included:

• - Non-Small Cell Lung Cancer (NSCLC): In previously untreated KRAS G12Ci-naïve patients, the objective response rate (ORR) was an impressive 58.8%, with a median progression-free survival (mPFS) of 12.2 months.
• - Colorectal Cancer (CRC): For patients who had undergone prior treatment, Elisrasib achieved an ORR of 46.9% and an mPFS of 9.5 months. In combination with cetuximab, ORR increased to 62.1%.
• - Pancreatic Ductal Adenocarcinoma (PDAC): A notable ORR of 65.0% was recorded, with mPFS reaching 13.5 months.

Moreover, in patients who had been treated with prior KRAS G12C inhibitors, Elisrasib still exhibited meaningful activity with an ORR of 32.3% and an mPFS of 8.1 months.

Safety Profile and Tolerance

Elisrasib was found to be well-tolerated among the different patient cohorts. The incidence of grade 3 or higher treatment-related adverse events (TRAEs) ranged between 8.7% and 15.6%. Notably, while combining with cetuximab did lead to a higher incidence of grade 3 TRAEs, these effects remained manageable. Only one transient, asymptomatic Grade 4 hypokalemia event occurred without any other severe TRAEs noted.

Expert Insights

Professor Byoung Chul Cho from Yonsei Cancer Center commented on the promising efficacy of Elisrasib, revealing that it demonstrates the capability of inducing lasting tumor responses even after previous treatments had failed. This highlights the potential of Elisrasib as a transformative therapy for patients with KRAS G12C mutations in lung cancer, noting cases where patients previously resistant to first-generation inhibitors experienced tumor shrinkage and significant disease control rates.

Other Presentations

Alongside the updates on Elisrasib, D3 Bio also introduced other advancements in its KRAS portfolio, including:

• - The first-in-human phase 1 study of D3S-002, a selective ERK1/2 inhibitor, aimed at advanced solid tumors with MAPK pathway mutations.
• - Clinical pharmacokinetic modeling related to D3S-003, an innovative oral dual-state KRAS G12D inhibitor.

Dr. George Chen, the founder and CEO of D3 Bio, expressed excitement about the robust clinical activity shown by Elisrasib, reinforcing the strength of their expanding KRAS-focused pipeline. He suggested that these data indicate the potential for Elisrasib to become a cornerstone therapy for KRAS G12C-driven malignancies.

About D3 Bio and Elisrasib

D3 Bio remains devoted to developing groundbreaking oncology therapeutics. Elisrasib is recognized for its thorough engagement with the GDP-bound form of KRAS G12C, inhibiting oncogenic signaling. Presently, it is being evaluated in global phase 2 trials targeting various KRAS G12C mutant solid tumors, encompassing NSCLC, CRC, and more.

For further insights and detailed information on ongoing studies, D3 Bio invites interested parties to visit their official website, www.d3bio.com.