Divarasib: New Lung Cancer Hope
Roche's Divarasib Shows Superiority in Lung Cancer, Poised to Be New Standard of Care
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Key Points
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Interim analysis of Krascendo-1 showed statistical significance for overall survival (OS) in this poor-prognosis KRAS G12C NSCLC population, strengthening the case for divarasib's durable benefit.
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Krascendo-1 data were described as having 'best-in-class potential' for divarasib compared with first-generation KRAS G12C inhibitors, underscoring substantial PFS improvements.
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Levi Garraway, Roche's chief medical officer, stated that the results could establish divarasib as a new standard of care for previously treated KRAS G12C NSCLC.
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Roche indicated it is evaluating divarasib both as monotherapy and in combinations without chemotherapy across different disease settings and treatment stages, signaling broad development plans beyond the current trial.
Roche announced on July 2, 2026 that its experimental drug divarasib beat two existing lung cancer pills in a head-to-head Phase III trial. The Krascendo-1 study showed divarasib improved both progression-free survival and overall survival compared to sotorasib and adagrasib — the only two approved KRAS G12C inhibitors — in previously treated non-small cell lung cancer (NSCLC), according to Nasdaq.
Roche Chief Medical Officer Levi Garraway said the results "confirm the potential of divarasib to improve clinical outcomes" and could "establish divarasib as a new standard of care" for this patient group. The drug has not yet been approved by any health authority. Roche says it plans to submit the data to regulators and present the full findings at upcoming medical meetings, according to MarketScreener.
A Direct Race That First-Gen Drugs Lost
Krascendo-1 is the first trial to ever pit a next-generation KRAS inhibitor directly against both sotorasib (Amgen's Lumakras) and adagrasib (BMS/Mirati's Krazati). Earlier trials measured these drugs against older chemotherapy, not each other. The 338-patient global study enrolled its first participant in September 2024, according to MarketScreener.
The older drugs had modest results. Sotorasib showed a median progression-free survival (PFS) of just 6.3 to 6.8 months in its Phase III trial, with no proven overall survival benefit. Adagrasib reached about 6.9 months of PFS. Divarasib posted a 59.1% response rate and a median PFS of 15.3 months in Phase I data — nearly double its rivals, according to Nasdaq.
Why Divarasib Is Built Differently From Its Rivals
KRAS G12C mutations occur in roughly 14% of NSCLC cases. For four decades after KRAS was identified as a cancer-driving gene in 1982, scientists called it "undruggable." The first approved drug in this class, sotorasib, only received FDA clearance in May 2021. Divarasib is engineered to be 5 to 20 times more potent and up to 50 times more selective than first-generation inhibitors, according to MarketScreener.
That extra precision appears to translate into fewer serious side effects. Only 11% of divarasib patients reported Grade 3 or higher treatment-related side effects in Phase I testing. By comparison, roughly 44% of adagrasib patients hit that threshold. Roche says no new safety signals appeared in Krascendo-1 and that most side effects were manageable and reversible, according to Nasdaq.
Divarasib Eyes First-Line Treatment and Combinations
Roche is not stopping at second-line therapy. Interim data from the separate Krascendo-170 trial, released in May 2026, showed a 73% response rate when divarasib was combined with pembrolizumab — a widely used immunotherapy — in first-line NSCLC patients. That trial targets patients who have not yet received any systemic therapy, according to MarketScreener.
Roche says it is evaluating divarasib as a single drug and in combinations without chemotherapy across multiple disease stages. The company is also testing divarasib in colorectal cancer and other solid tumors. If approved, analysts expect divarasib to capture significant market share from sotorasib and adagrasib, in a KRAS drug market projected to grow from $124 million in 2026 to $190 million by 2035, according to Nasdaq.
What Comes Next Before Divarasib Can Reach Patients
Divarasib is still investigational. Roche must submit the Krascendo-1 data to the FDA and other regulators before the drug can be approved. The FDA has recently pushed for stronger overall survival data before granting full approvals in the KRAS space. Roche says it met the overall survival endpoint, but regulators will review the full data set before deciding how broad the drug's label will be, according to MarketScreener.
The drug already holds FDA Breakthrough Therapy Designation, which speeds up the review process. Analysts at Morningstar called the data "best-in-class." The LUNGevity Foundation described the results as "encouraging." A regulatory submission is expected before the end of 2026, with a possible approval decision in 2027, according to Nasdaq.
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