Median survival prolonged by 5.7 months! Roche (RHHBY.US) lung cancer new drug wins in head-to-head trial, major catalyst for oncology business

According to Zhitong Finance APP, Swiss healthcare and pharmaceutical giant Roche's investigational lung cancer drug divarasib extended the median survival time of patients by nearly six months in a late-stage clinical trial compared to rival therapies, further strengthening the company's oncology portfolio.

Among patients with advanced non-small cell lung cancer driven by KRAS G12C gene mutations, the therapy outperformed the sotorasib from biopharma giant Amgen (AMGN.US) and the blockbuster adagrasib from Bristol Myers Squibb (BMY.US). These trial participants had previously received other treatments, including chemotherapy.

The study results were announced Sunday at the European Society for Medical Oncology (ESMO) Congress in Madrid. The research directly compared divarasib with existing KRAS G12C inhibitors, rather than with chemotherapy, providing evidence of divarasib's potential advantages over current therapies.

Researchers also reported that the drug showed good safety, consistent with previous findings on divarasib and similar drugs. Fewer patients experienced serious adverse events or discontinued treatment due to side effects.

Wall Street analysts surveyed by institutions almost unanimously predict that by 2032, annual sales of divarasib will exceed 1 billion Swiss francs (1.3 billion USD); if approved, it is expected to become a major revenue source for Roche's oncology business.

Roche is conducting further trials to assess divarasib's efficacy in earlier stages of lung cancer treatment. One study is combining divarasib with Merck's (MRK.US) blockbuster cancer therapy Keytruda to explore chemo-free regimens for newly diagnosed patients; another is exploring its post-surgical use to reduce the risk of cancer recurrence.

Life Extension by 5.7 Months: Roche Strengthens Competitiveness of New Lung Cancer Drug with Head-to-Head Trial

The core breakthrough Roche announced this time is that in previously treated advanced non-small cell lung cancer patients with KRAS G12C mutations, divarasib improved both disease control and overall survival compared to existing targeted therapy control groups.

The phase III Krascendo 1 trial, disclosed on October 25 at the ESMO Congress, enrolled 338 patients: the divarasib group achieved a median Overall Survival (OS) of 17.7 months versus 12.0 months in the control group, extending survival by 5.7 months and reducing the risk of death by 44%; median Progression-Free Survival (PFS) increased from 5.7 months to 9.8 months. The direct comparison here was with existing targeted therapies—Amgen's sotorasib and Bristol Myers Squibb's adagrasib—providing solid evidence to support the clinical value of this new drug.

“Head-to-head” refers to assigning patients to different treatment groups in the same clinical trial, allowing direct comparison of a drug's efficacy and safety. In this case, Roche’s divarasib was compared against the control group using sotorasib or adagrasib.

The underlying mechanism behind divarasib is that the KRAS G12C mutation causes abnormal activation of cell growth signals, and divarasib precisely binds to the mutant protein to inhibit the tumor's growth-driving signals. KRAS normally acts as a molecular switch regulating cell proliferation; G12C means glycine at position 12 of the protein is replaced by cysteine. Divarasib is a “covalent inhibitor” that locks the mutated protein in an inactive GDP-bound state, blocking downstream proliferative signals.

According to reports, a preclinical study showed that divarasib has higher potency and selectivity than existing drugs, providing a pharmacological basis for stronger target inhibition. Clinical benefits are also accompanied by good tolerability: the rate of severe treatment-related adverse events was 7.8% (vs. 15.2% in the control group), and the proportion of patients discontinuing due to treatment-related adverse events was 4.8% (vs. 11.7% for controls). Better disease control and fewer toxicity-driven discontinuations support continuous therapy.

From Clinical Advantage to Sales Growth: Roche Competes for Next Wave of Oncology Business Expansion

For Roche’s ADR shares (RHHBY.US) in the US stock market and its shares in Europe, the investment value is that divarasib’s survival data directly outperform existing drugs, likely increasing clinical adoption of divarasib once approved and enhancing its market share potential. According to a Bloomberg analyst survey cited in reports, annual sales of this drug are expected to surpass 1 billion Swiss francs by 2032, about $1.3 billion. This potential increment is highly meaningful for Roche—the company’s Q3 sales were 16.13 billion Swiss francs, with a 7% growth at constant exchange rates, but mature product Xolair was impacted by cheaper competition, and sales underperformed expectations. Therefore, the commercial value of the new drug must be realized through differentiated efficacy, prescription penetration, and incremental revenue to maintain growth momentum after mature products.

Greater expansion potential lies in moving the treatment to earlier lines. Krascendo 2 is testing whether divarasib combined with pembrolizumab (Keytruda) can serve as a chemo-free regimen in first-line treatment of untreated advanced lung cancer; Krascendo 3 assesses its value as adjuvant therapy after resectable lung cancer surgery. The former pathway synergizes tumor signal inhibition and immune suppression release, while the latter aims to control post-surgery residual cancer cells and lower recurrence risk. These two approaches expand both the treatment lines and disease stages: if subsequent trials succeed and divarasib is approved, its market could extend from previously treated patients to a broader patient population, forming the main basis for its increased long-term sales potential.