Key Highlights
- Roche said its KRAS-targeting drug divarasib met goals in a late-stage lung cancer study.
- The trial compared divarasib against existing treatment options in previously treated patients.
- The company is now looking at a larger first-line market opportunity through another ongoing study.
Roche has reported positive results from a head-to-head study of its KRAS-targeting lung cancer drug, marking an important step as the company looks to enter a growing but competitive cancer treatment market.
The drug, called divarasib, is being developed for patients with a KRAS G12C mutation. It is a genetic change found in around 14% of non-small cell lung cancer cases.
The KRAS gene normally helps control how cells grow by acting like an on-and-off switch. But in patients with the G12C mutation, that switch stays on, causing continuous cell growth that can fuel tumor development.
Roche Looks to Enter an Already Competitive Market
The KRAS-targeting drug space is still relatively new.
Amgen became the first company to win approval in this area back in 2021. A year later, Bristol Myers Squibb secured another foothold in the market after acquiring Mirati Therapeutics, the developer of Krazati, in a deal worth $4.8 billion.
Now Roche is trying to secure its own position.
The company said its late-stage trial, called Krascendo-1, showed strong enough results that it could support divarasib becoming a standard treatment option for lung cancer patients who have already received earlier therapies.
“This should establish divarasib as a new standard of care for previously treated lung cancer patients with this genetically defined tumor subtype,” said Levi Garraway in the company’s statement.
A Bigger Opportunity May Still Lie Ahead
While the latest results strengthen Roche’s position, analysts believe the bigger commercial opportunity is still in first-line treatment, where patients receive the drug earlier in their cancer journey.
Roche is already testing that through its KRAScendo-2 study.
That trial is evaluating divarasib in combination with Keytruda, the blockbuster cancer therapy from Merck & Co., against the current combination of Keytruda and chemotherapy.
Analysts at Jefferies estimate success in that setting could unlock a much bigger revenue opportunity, which is potentially worth up to 5 billion Swiss francs, compared to around 1 to 2 billion francs in the second-line market.
For now, Roche has secured an important win, but the bigger test for divarasib may still be ahead.