Single-Agent Divarasib in Patients With KRAS G12C –Positive Non–Small Cell Lung Cancer: Long-Term Follow-Up of a Phase I Study

Jul 9, 2025Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Long-Term Follow-Up of Divarasib Alone in Patients with KRAS G12C Lung Cancer

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Abstract

Among 65 patients with advanced-positive non-small cell lung cancer, the confirmed objective response rate to divarasib was 55.6%.

Divarasib, an oral KRAS G12C inhibitor, showed a manageable safety profile over a follow-up period of at least one year.
Of the participants, 31 patients (48%) continued treatment beyond one year without significant safety concerns.
The median duration of response for patients with measurable disease was 18.0 months.
The median progression-free survival was 13.8 months for the overall population and 15.3 months for those on the 400-mg dose.

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Divarasib (GDC-6036), an oral, highly potent and selective next-generation KRAS G12C inhibitor, has demonstrated a manageable safety profile and promising antitumor activity in patients with advanced-positive non-small cell lung cancer (NSCLC). Here, we report long-term (≥1 year) follow-up of single-agent divarasib from the ongoing, open-label, and multicenter phase I study (ClinicalTrials.gov identifier: NCT04449874). The primary objective was safety, and the other objectives included preliminary antitumor activity. Overall, 65 patients with advanced-positive NSCLC received single-agent oral divarasib 50-400 mg once daily and 31 patients (48%) were treated beyond 1 year. Divarasib continued to be well tolerated, and the safety profile beyond 1 year was consistent with the overall safety profile. In patients with measurable disease at baseline across all dose levels (n = 63), the confirmed objective response rate was 55.6% (95% CI, 42.5 to 68.1), and the median duration of response was 18.0 months (95% CI, 11.1 to 24.9). The median progression-free survival was 13.8 months (95% CI, 9.8 to 25.4) in the overall population (N = 65) and 15.3 months (95% CI, 12.3 to 26.1) among patients assigned to the 400-mg dose level (n = 44). With extended follow-up, divarasib demonstrated long-term safety and antitumor activity in patients with advanced-positive NSCLC. KRAS G12C KRAS G12C KRAS G12C

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Single-Agent Divarasib in Patients With KRAS G12C –Positive Non–Small Cell Lung Cancer: Long-Term Follow-Up of a Phase I Study

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