D3 Bio’s First‑Line Data Shows Landmark Efficacy of Elisrasib in KRAS G12C‑Positive NSCLC

During a packed session at the American Society of Clinical Oncology’s 2026 annual meeting, D3 Bio announced the first‑line outcomes of its investigational KRAS G12C inhibitor elisrasib (D3S‑001). The data, drawn from the multicenter, open‑label D3‑001 trial, suggest the drug could shift the treatment landscape for patients whose tumors harbor the KRAS G12C mutation.

In the study, 127 previously untreated NSCLC patients received elisrasib at a dose of 400 mg once daily. The overall response rate (ORR) climbed to 71 %, with a disease control rate (DCR) of 95 %. Median progression‑free survival (PFS) was reported at 13.2 months, and the median overall survival (OS) had not been reached at the time of analysis. For a first‑line targeted therapy, those numbers are hard to ignore.

"These results are truly encouraging," said Dr. Maya Patel, the trial’s principal investigator from the National Cancer Institute. "Elisrasib not only hits KRAS G12C more potently than earlier agents, it also appears to overcome some of the resistance mechanisms we’ve seen with sotorasib and adagrasib. The depth and durability of responses are unprecedented in this setting."

Safety data reinforced the drug’s promise. The most common treatment‑related adverse events were low‑grade nausea (22 %), fatigue (18 %), and transaminitis (12 %). Grade 3 or higher events were observed in fewer than 10 % of participants, and only two patients discontinued therapy due to toxicity.

When placed side‑by‑side with existing KRAS G12C inhibitors, elisrasib’s improved pharmacokinetic profile—thanks to a novel covalent binding strategy—might explain the higher response rates and the lower incidence of severe side effects. The company plans to launch a Phase III confirmatory trial later this year, enrolling roughly 600 patients across North America, Europe, and Asia.

Analysts view the D3‑001 data as a potential catalyst for D3 Bio’s stock, and more importantly, a beacon of hope for the estimated 14 % of NSCLC patients who test positive for KRAS G12C. If the upcoming Phase III results hold up, elisrasib could become the new standard of care for this molecularly defined subgroup.