Roche and Jazz Pharmaceuticals Announce Promising Results in Phase III Lung Cancer Trial

Roche and Jazz Pharmaceuticals have unveiled updated Phase III data for a combination therapy of their drugs Tecentriq and Zepzelca, demonstrating improved survival rates in small cell lung cancer (SCLC) patients. The results, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The Lancet, have bolstered the companies' plans to seek FDA approval for the drug combination in first-line maintenance therapy for SCLC.

Trial Results Show Significant Survival Benefits

The Phase III study, sponsored by Roche and co-funded by Jazz, enrolled 660 patients with extensive-stage SCLC. After receiving four cycles of carboplatin, etoposide, and Tecentriq as induction therapy, 483 eligible patients without disease progression were randomized to receive either Tecentriq alone or in combination with Zepzelca.

The results showed significant improvements in both progression-free survival (PFS) and overall survival (OS) for patients receiving the combination therapy:

• Median PFS: 5.4 months for the combination arm vs. 2.1 months for Tecentriq alone
• Median OS: 13.2 months for the combination arm vs. 10.6 months for Tecentriq alone

These differences in PFS and OS were statistically significant, suggesting a strong treatment effect for the combination therapy.

Potential Impact on Current Treatment Landscape

If approved, the Tecentriq-Zepzelca combination could offer an alternative to existing monotherapy treatments in the maintenance setting, such as Roche's Tecentriq and AstraZeneca's Imfinzi. Analysts from Truist Securities noted that while cross-trial comparisons can be flawed, the data suggest that the combination therapy may be as effective as current monotherapy options.

Rob Iannone, chief medical officer at Jazz, expressed optimism about the FDA approval process, stating, "We expect to get priority review, which would allow us to get an approval this year." Amal Melhem-Bertrandt, oncology therapy area head at Jazz, added that the company has not experienced any disruptions in the FDA review process despite recent changes at the agency.

Competitive Landscape and Future Developments

The SCLC treatment landscape continues to evolve, with several companies working on improving current therapies:

• BioNTech is conducting a Phase III trial of its PD-L1xVEGF-A bispecific antibody in SCLC, co-developed with Bristol Myers Squibb in a deal worth up to $11.1 billion.
• Daiichi Sankyo and Amgen are also targeting SCLC maintenance therapy with their respective candidates.

These developments highlight the ongoing efforts to enhance treatment options for SCLC patients and the competitive nature of the pharmaceutical industry in this area.