Revolution Medicines RVMD announced that it has begun treating patients in the phase III RASolute 305 study, evaluating its pipeline candidate zoldonrasib in combination with chemotherapy in first-line metastatic RAS G12D pancreatic ductal adenocarcinoma (PDAC).
Zoldonrasib is RVMD’s investigational oral RAS(ON) G12D-selective inhibitor designed to suppress the active RAS G12D mutation, one of the most common oncogenic drivers across cancers. As no approved targeted therapies currently exist for RAS G12D-mutated tumors, the candidate represents a potentially significant treatment opportunity. Per management, zoldonrasib has shown encouraging antitumor activity and a favorable safety profile in early clinical studies.
Year to date, RVMD shares have skyrocketed 112.9% against the industry’s 0.1% decline.
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RVMD’s RASolute 305 Study Design & Key Endpoints
In the global late-stage RASolute 305 study, the participants are being given either zoldonrasib plus investigator-selected standard-of-care chemotherapy or placebo plus chemotherapy. Chemotherapy options include modified FOLFIRINOX or the combination of gemcitabine and nab-paclitaxel, both established frontline treatment regimens for metastatic pancreatic cancer.
The study’s co-primary endpoints are progression-free survival (PFS) and overall survival (OS). Secondary endpoints include additional measures such as antitumor efficacy, safety, tolerability and patient-reported outcomes assessing quality of life.
The study is designed to evaluate whether combining zoldonrasib with frontline chemotherapy can improve survival outcomes for patients with metastatic RAS G12D PDAC.
Pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer, is often diagnosed at an advanced stage due to limited early symptoms and detection options. More than 90% of PDAC tumors harbor RAS mutations, with RAS G12D present in about 40% of patients and associated with particularly poor outcomes. Metastatic PDAC remains one of the deadliest cancers in the United States, with a five-year survival rate of around 3%.
Beyond pancreatic cancer, Zoldonrasib is being evaluated both as a standalone therapy and in combination with other treatments, including daraxonrasib and standard-of-care regimens, across multiple lung and gastrointestinal cancer indications.
RVMD Expands Late-Stage Presence in Metastatic PDAC
Revolution Medicines is advancing a broad pancreatic cancer portfolio built around its proprietary RAS(ON) inhibitor platform. The company's strategy spans both previously treated and first-line metastatic PDAC. In addition to the late-stage RASolute 305 study evaluating zoldonrasib in metastatic RAS G12D PDAC, the company is developing its lead pipeline candidate daraxonrasib in the ongoing phase III RASolute 303 study, as a monotherapy and in combination with chemotherapy for the first-line treatment of metastatic PDAC.
In April, the company announced positive top-line data from the phase III RASolute 302 study, which evaluated daraxonrasib, in previously treated metastatic PDAC patients. The study successfully met its primary endpoints, demonstrating significant improvements in both OS and PFS versus standard chemotherapy.
RVMD's Zacks Rank & Stocks to Consider
Revolution Medicines currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Indivior Pharmaceuticals INDV, Liquidia Corporation LQDA and Immunocore IMCR, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 11.3% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, estimates for Liquidia’s earnings per share remained unchanged at $2.97 for 2026 and $4.81 for 2027. LQDA shares have gained 114.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, earnings per share estimates for Immunocore’s 2026 were unchanged at 6 cents for 2026 and 87 cents for 2027. IMCR shares have lost 16% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.
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Revolution Medicines, Inc. (RVMD): Free Stock Analysis Report
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This article originally published on Zacks Investment Research (zacks.com).