Roche RHHBY reported positive results from the late-stage Krascendo 1 study evaluating experimental candidate, divarasib, in patients with previously treated KRAS G12C non-small cell lung cancer (NSCLC).
Divarasib is an investigational, next-generation, oral, KRAS G12C inhibitor. This phase III, randomized, open-label, multicentre study is evaluating the efficacy and safety of divarasib monotherapy versus Amgen’s AMGN Lumakras (sotorasib) or Bristol Myers’ BMY Krazati (adagrasib) in patients with previously treated KRAS G12C-mutant advanced or metastatic NSCLC.
The study results demonstrate best-in-class potential for patients with previously treated advanced KRAS G12C NSCLC.
Year to date, shares of RHHBY have gained 2.9% compared with the industry’s growth of 13.7%.
More on RHHBY’s KRAS G12C inhibitor for NSCLC
Per RHHBY, Krascendo 1 is the only global head-to-head study evaluating a Kirsten rat sarcoma virus (KRAS) G12C inhibitor in direct comparison with first-generation KRAS G12C inhibitors.
The study enrolled 338 adults who were randomly assigned to receive either divarasib once daily or one of the approved KRAS G12C inhibitors, Lumakras once daily or Krazati twice daily.
The study met its primary and key secondary endpoints, with divarasib demonstrating clinically meaningful and statistically significant improvements in progression-free survival and overall survival.
Its safety profile was consistent with prior findings, with no new safety signals identified and treatment-related adverse events remaining manageable and reversible.
Per Roche, results should establish divarasib as a new standard of care for previously treated patients with KRAS G12C-mutated lung cancer.
Effective therapies for KRAS G12C-mutated NSCLC remain a significant unmet need in lung cancer treatment. The KRAS G12C mutation is one of the most common KRAS oncogenic alterations, occurring in approximately 14% of NSCLC cases and is associated with poor patient prognosis.
Divarasib received Breakthrough Therapy Designation from the FDA in 2022 and was granted Orphan Drug Designation in 2026 for the treatment of KRAS G12C-mutated NSCLC.
Data from the Krascendo 1 study will be presented at a forthcoming medical meeting and submitted to regulatory authorities to support efforts to make this potential treatment available to patients with KRAS G12C-mutated NSCLC as quickly as possible.
A potential approval will strengthen RHHBY’s oncology portfolio.
Roche’s lung cancer portfolio includes approved therapies, such as Alecensa (alectinib), Tecentriq (atezolizumab) and Rozlytrek (entrectinib). The company’s pipeline spans three major areas of focus – small cell lung cancer, NSCLC with actionable genomic alterations, and NSCLC without actionable genomic alterations.
Amgen’s Lumakras received accelerated approval from the FDA on May 28, 2021, for patients with KRAS G12C-mutated NSCLC.
Last year, Amgen obtained FDA approval for Lumakras in combination with Vectibix (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
BMY added Krazati to its portfolio following the acquisition of Mirati Therapeutics.
RHHBY’s Efforts to Diversify Pipeline
Strong growth from key drugs like Ocrevus, Vabysmo, Hemlibra and Phesgo has helped RHHBY offset declining revenues from legacy drugs.
Roche has a strong and diversified pipeline spanning multiple therapeutic modalities.
The FDA recently accepted and granted Priority Review to RHHBY’s new drug application for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), for the adjuvant treatment of adults with ER-positive, HER2-negative stage I–III breast cancer. A regulatory decision is expected by Nov. 30, 2026.
Roche recently entered into an exclusive licensing and collaboration agreement with Nurix Therapeutics NRIX to co-develop and co-commercialize bexobrutideg (NX-5948) across malignant hematology, immunology and neurology indications.
The deal expands Roche’s hematology pipeline while providing opportunities to advance the therapy across immunology and neurology indications.
Under the agreement, Nurix will receive $700 million upfront and could earn up to $2.3 billion in total through development, regulatory, and commercial milestone payments. Roche will fund 60% of development costs, with Nurix covering the remaining 40%.
The companies will jointly commercialize bexobrutideg in the United States, sharing profits and losses equally. Outside the United States, Roche will lead commercialization, while Nurix will receive tiered royalties ranging from the low- to high-teens.
RHHBY’s Zacks Rank
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Beyond Nvidia: AI’s Second Wave Is Here
The AI revolution has already minted millionaires. But the stocks everyone knows about aren’t likely to keep delivering the biggest profits. AI’s second wave is moving from infrastructure to implementation and these companies are at the forefront of this transition, positioned to become what Amazon and Google were to the internet era.
See Stocks Now >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report
Amgen Inc. (AMGN) : Free Stock Analysis Report
Nurix Therapeutics, Inc. (NRIX) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
Zacks Investment Research
