Roche and Jazz Pharmaceuticals Report Positive Phase III Results for Lung Cancer Combination Therapy

Roche and Jazz Pharmaceuticals have announced promising results from a Phase III clinical trial evaluating a combination therapy for small cell lung cancer (SCLC). The study, which combined Roche's Tecentriq (atezolizumab) with Jazz's Zepzelca (lurbinectedin), demonstrated significant improvements in both progression-free survival (PFS) and overall survival (OS) compared to Tecentriq monotherapy.

Trial Design and Results

The Phase III trial enrolled 660 patients with extensive-stage SCLC. Following four cycles of induction therapy with carboplatin, etoposide, and Tecentriq, 483 eligible patients without disease progression were randomized to receive either Tecentriq alone or in combination with Zepzelca.

Key findings from the study include:

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

Both PFS and OS differences were reported as statistically significant, suggesting a strong treatment effect for the combination regimen.

Regulatory Implications and Market Outlook

Jazz Pharmaceuticals has filed for FDA approval of the Tecentriq-Zepzelca combination, with expectations of priority review and potential approval later this year. If approved, this combination therapy could provide an alternative to existing monotherapy treatments from Roche and AstraZeneca in the first-line maintenance setting for SCLC.

Rob Iannone, Chief Medical Officer at Jazz, expressed optimism about the regulatory timeline, 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

The Tecentriq-Zepzelca combination enters a competitive field for SCLC maintenance therapy. Currently, patients have access to Roche's Tecentriq or AstraZeneca's Imfinzi (durvalumab) as monotherapy options. Analysts from Truist Securities note that the combination therapy's efficacy appears comparable to existing treatments, with the potential for improved outcomes.

Other companies are also developing therapies for this indication:

• BioNTech and Bristol Myers Squibb are collaborating on a PD-L1xVEGF-A bispecific antibody, which has shown promising Phase II results.
• Daiichi Sankyo and Amgen are pursuing SCLC maintenance therapy programs.

As the landscape evolves, the Tecentriq-Zepzelca combination may face competition from these emerging therapies in the future.