A month after reporting that its RAS inhibitor daraxonrasib doubled survival in advanced pancreatic cancer, Truist said Revolution Medicines “is evolving into a major revenue-generating oncology company,” and projects an approval in second-line disease by the end of the third quarter.
Revolution Medicines’ groundbreaking pancreatic cancer drug will likely gain approval by the third quarter of this year, analysts at Truist Securities said Monday. According to the firm, the potential FDA greenlight would mark just the beginning of a dynasty for the California-based biotech.
A little over a month ago, Revolution stunned the oncology space when its RAS inhibitor daraxonrasib doubled survival in metastatic pancreatic ductal adenocarcinoma (PDAC)—a disease that carries just a 13% survival rate five years after diagnosis. Now, Truist is hailing the company as potentially “the next oncology titan.”
“In our view, RVMD is evolving into a major revenue-generating oncology company, with daraxonrasib (“daraxon”) emerging as one of the most important drugs in PDAC and broader RAS-mutant cancers this decade,” the analysts wrote. Truist has now assumed coverage of Revolution with a buy rating.
The biotech is “building durable competitive moats in the RAS landscape with growing halo effect that could support potential faster trial execution, regulatory engagement, and payer/access flexibility,” the analysts continued.
Truist is projecting an approval for daraxonrasib in second-line PDAC by the end of the third quarter based on the results of the Phase 3 RASolute 302 trial, in which patients treated with Revolution’s drug survived 13.2 months compared to 6.7 months for those on chemotherapy, and an expanded access treatment protocol greenlit by the FDA on May 1. Daraxonrasib was awarded an FDA Commissioner’s National Priority Voucher last October—a regulatory token that should elicit a speedier review for the drug.
Truist also anticipates Revolution owning the PDAC market for the foreseeable future. “While competitor agents may demonstrate incremental efficacy/tolerability improvements . . . achieving approval via superiority or non-inferiority against daraxon would likely require large and expensive trials with operational and ethical challenges,” they wrote.
While clearly effective, daraxonrasib does come with some side effects—most conspicuously a rash. Anna Berkenblit, chief scientific and medical officer at the Pancreatic Cancer Action Network, told BioSpace earlier this month that most patients develop a rash, but she noted that it is mild to moderate in severity for the majority of patients.
Several companies are working hard to improve upon tolerability and efficacy of their drugs in the space. Over at Immuneering, the biotech’s atebimetinib is designed to inhibit the MEK protein kinase, an approach CEO Zeskind previously told BioSpace contributes to the drug’s positive tolerability profile by allowing partial access to the MAPK pathway, which plays a role in helping healthy cells to grow and divide “at the right pace.” RAS treatments inhibit this process, he said, because they “basically shut down this pathway 24/7.” Atebimetinib is currently in a Phase 3 trial for first-line PDAC.
For daraxonrasib, Truist also noted “growing discussions” about the potential for accelerated approval in first-line PDAC based on interim surrogate endpoints from the RASolute 303 trial, which is set to read out in June 2028, according to ClinicalTrials.gov. The trial—which is evaluating the drug as either a monotherapy or in combination with gemcitabine and nab-paclitaxel—kicked off in March this year.
In its Monday note, Truist also pointed to value beyond pancreatic cancer in Revolution’s pipeline, highlighting daraxonrasib’s expansion into non-small cell lung cancer (NSCLC). In second-line NSCLC, early data “appear competitive,” and supportive of the ongoing Phase 3 RASolve 301 study. Primary completion of this trial is expected in December 2027, per ClinicalTrials.gov.
Next up for Revolution is a presentation of full RASolute 302 results at the American Society of Clinical Oncology’s annual meeting later this month. Truist is expecting overall response, duration of response and progression-free survival data, which “could help fine-tune our treatment duration assumptions.”
Revolution has understandably been a top takeover target. There were rumors late last year that current oncology titan Merck had been in talks to acquire the biotech, but those negotiations fell apart after the two companies failed to reach an agreement on the purchase price, The Wall Street Journal reported in January. Merck was reportedly offering between $28 billion to $32 billion for the upwardly mobile company.
