Revolution Medicines drug almost doubles survival in pancreatic cancer in key trial

"Revolution Medicines" announced on Monday that its oral anti-tumor drug "adagrasib" has nearly doubled the overall survival of patients with previously treated metastatic pancreatic cancer compared to standard intravenous chemotherapy. Following the news, the company's shares jumped over 30% in pre-market trading.

Significant results from RASolute 302

In the phase 3 "RASolute 302" clinical trial, "adagrasib" - a once-daily tablet - provided a median overall survival of 13.2 months versus 6.7 months with chemotherapy in the "intention-to-treat" population. The reported hazard ratio is 0.40 with a p-value below 0.0001, according to company documents filed with the US Securities and Exchange Commission (SEC). The drug also demonstrated a statistically significant improvement in progression-free survival - the second co-primary endpoint in the study. According to "Revolution Medicines", "adagrasib" is generally well tolerated and no new safety signals have been recorded.

"These results represent a potentially transformative advance for patients and confirm the ability of "adagrasib" to change treatment approaches," the company said in a press release. According to the first interim analysis, all progression-free survival and overall survival data are considered final.

The Redwood City, California-based company says it intends to submit the results to regulatory authorities worldwide, including the U.S. Food and Drug Administration (FDA), as part of a future application for registration of a new medicinal product. "Adagrasib" already has "breakthrough therapy" status from the FDA for previously treated metastatic pancreatic cancer with KRAS G12 mutations - a designation received in June 2025.

Years of development and a different mechanism

The new data builds on earlier phase 1 results, according to which the median overall survival in patients with RAS G12X mutations treated with "adagrasib" as second-line therapy for pancreatic cancer was 13.1 months - significantly above the approximate 6-7 months typical for standard chemotherapy. At the end of 2025, the inclusion of participants in "RASolute 302" is completed - a global randomized trial in which monotherapy with "adagrasib" is compared to chemotherapy of the researcher's choice in about 500 patients.

Pancreatic ductal adenocarcinoma is among the cancers with the worst prognosis, and RAS mutations are at the root of almost all cases of this tumor. The mechanism of action of "adagrasib" differs fundamentally from earlier RAS-targeted drugs: it blocks the active ("on") state of several RAS variants instead of targeting a single specific mutation in an inactive form.

Expanding ambitions and interest from the "big ones"

"Revolution Medicines" is currently conducting four global phase 3 clinical trials with "adagrasib" - three in pancreatic cancer and one in non-small cell lung cancer. Earlier this month, the company began treating patients in the "RASolute 303" trial for first-line therapy in pancreatic cancer, and in December 2025, randomized the first participant in the adjuvant study "RASolute 304". Nine scientific reports dedicated to the candidate drugs in the company's portfolio are planned at the upcoming AACR annual meeting in San Diego this week.

The information published in January on negotiations between "Merck" and "Revolution Medicines" for a possible acquisition worth between $28 and $32 billion further focused attention on the shares. The data announced on Monday - some of the most impressive survival rates ever recorded in second-line therapy for pancreatic cancer - are likely to boost interest from both regulators and potential buyers.