Analysts said the data suggest “a strong treatment effect.” Jazz has filed for FDA approval for the combination, which could offer an alternative to monotherapy treatments from Roche and AstraZeneca.
Roche and Jazz Pharmaceuticals have shared updated Phase III data on a combination of their medicines Tecentriq and Zepzelca, furthering plans to win FDA approval for the drug cocktail in small cell lung cancer in a first-line maintenance setting this year.
Investigators shared the results in an abstract for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and a paper published in The Lancet. Truist Securities analysts said in a note to investors that researchers provided “incremental updates” in an oral ASCO presentation, adding that the latest look at the data was consistent with the abstract and the paper.
Jazz has filed for FDA approval for the combination. Rob Iannone, chief medical officer at Jazz, recently told BioSpace he expects “to get priority review, which would allow us to get an approval this year.” Amal Melhem-Bertrandt, oncology therapy area head at Jazz, said at a Bank of America event last month that amid changes at the FDA the company had not “seen any disruption, thankfully, and things continue to go on time.”
If the filing is approved, Zepzelca will offer an alternative to Tecentriq or AstraZeneca’s rival checkpoint inhibitor Imfinzi in maintenance therapy.
The new study, which is sponsored by Roche and co-funded by Jazz, enrolled 660 people with extensive-stage small cell lung cancer (SCLC). Patients received four cycles of carboplatin, etoposide and Roche’s checkpoint inhibitor Tecentriq as induction therapy. After induction, investigators randomized 483 eligible patients without disease progression to receive just Tecentriq or Jazz’s Zepzelca together with Tecentriq.
The cocktail extended patients’ progression-free (PFS) and overall survival (OS). Median PFS was 5.4 months in the combination arm, compared to 2.1 months in people treated with Tecentriq alone. Median OS was 13.2 months and 10.6 months, respectively, in the combination and monotherapy arms. The differences in PFS and OS between the arms were statistically significant.
Currently, patients have access to Tecentriq or AstraZeneca’s rival checkpoint inhibitor Imfinzi in maintenance therapy. Median PFS in Tecentriq and Imfinzi trials was 5.2 months and 5.1 months, respectively, according to an analyst note from Truist on Monday. Though cross-trial comparisons can be flawed, the data suggest that Zepzelca is about as effective as Tecentriq or Imfinzi, and Truist analysts said Jazz and Roche’s combo has “a strong treatment effect.”
Other companies are also seeking to improve on Imfinzi and Tecentriq. BioNTech is running a Phase III trial of its PD-L1xVEGF-A bispecific in SCLC. The candidate, which Bristol Myers Squibb is co-developing through a deal worth up to $11.1 billion, achieved median PFS and OS of 6.9 months and 16.8 months, respectively, in a Phase II trial. Daiichi Sankyo and Amgen are also targeting SCLC maintenance therapy.
Zepzelca is already approved in second-line SCLC. Sales of the drug fell 16% to $63 million in the first quarter. Jazz CFO Philip Johnson discussed the dip at the Bank of America event last month, explaining that the roll out of Amgen’s Imdelltra as a second-line treatment and “great data” on Imfinzi in first-line, limited-stage patients hurt sales. Improved initial therapies delay the need for second-line drugs such as Zepzelca.
