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Jazz Pharmaceuticals announced Tuesday that adding its small cell lung cancer drug Zepzelca to a maintenance treatment regimen for extensive-stage small cell lung cancer cut the risk of death in a pivotal trial. In a Phase 3 study called IMforte, a subset of lung cancer patients first received initial induction therapy with a combination of chemotherapy agents and Roche’s checkpoint inhibitor Tecentriq. Then, they received either Tecentriq alone or in combination with Zepzelca. Jazz said the combination of Zepzelca and Tecentriq maintenance therapy beat Tecentriq alone on both overall survival and progression-free survival. Jazz CMO Rob Iannone said in a statement the company plans to submit an application to the FDA in the first half of 2025 to use the combination in first-line maintenance for extensive-stage small cell lung cancer. Jazz and Roche also plan to submit the trial data to be presented at a future medical meeting. Jazz said the Zepzelca-Tecentriq combination was “generally well-tolerated.” Zepzelca was first greenlit by the FDA in 2020 under the accelerated approval pathway as a second-line option for metastatic small cell lung cancer patients. The drug failed a confirmatory study in 2022, but the FDA said it wouldn’t pull the drug from the market as the confirmatory study used a different dose from the approved regimen. Jazz then planned at the time to use both IMforte and another study called LAGOON as confirmatory studies. LAGOON is estimated to wrap up in 2026, according to a federal clinical trials database. In an emailed statement, Jazz said, “We view these data as potentially being sufficient to confirm benefit in SCLC inclusive of our current 2L indication and look forward to engaging with the FDA.” Stifel analysts said the new data could be “cannibalizing Zepzelca as SoC for 2L, but offering meaningful expansion with a multi-fold larger (more fit) population and a longer duration of treatment.” Editor’s note: This story was updated to include a statement from Jazz.

Today, a brief rundown of news from Pfizer and Jazz Pharmaceuticals, as well as updates from Akeso and Inventiva that you may have missed.Lexington, Massachusetts-based Triana Biomedicines has a big pharmaceutical partner in Pfizer, which has agreed to pay it $49 million to explore the biotechnology companys work developing molecular glue degraders. Triana will identify promising degrader candidates for use in oncology, on which Pfizer will hold an exclusive option to license. Molecular glue degraders work by sticking together a protein target to cellular enzymes that mark those proteins for destruction. Ned PagliaruloFormer chairman and CEO of the investment firm Vanguard Tim Buckley will join Pfizers board of directors, the pharmaceutical company said Tuesday. His appointment expands the board to 14 members, 13 of whom are independent. Pfizers board is currently under pressure from activist investor Starboard Value, which is meeting with the companys executive team on Wednesday. Ned PagliaruloTreatment with Jazz Pharmaceuticals drug Zepzelca and Roches Tecentriq outperformed Tecentriq alone when used as maintenance therapy in people with small cell lung cancer. The data, from a Phase 3 study called IMforte, showed Jazzs combination led to improved overall survival and progression-free survival versus Tecentriq. In a Tuesday statement, Jazz said it plans to ask the Food and Drug Administration for an expanded approval for Zepzelca. Ned PagliaruloAn experimental gene therapy for Parkinson's disease has met the main goal of a small clinical trial, where it was shown to be safe, well-tolerated and not the cause of any serious side effects. The trial also explored whether the therapy was effective and, according to its developer MeiraGTx, there were encouraging signs. The CEO of MeriaGTx, Alexandria Forbes, said the results will “underpin“ discussions with drug regulators in the U.S., Europe, and Japan as her company moves toward beginning a late-stage trial that could support approval. Shares of the company were up about 13% by late morning Tuesday. Jacob BellChina-based biotechnology company Akeso has raised $250 million through a private stock offering meant to fund international trials of its pipeline of antibody drugs for cancer and autoimmune diseases. The raise announced Monday comes a month after development partner Summit Therapeutics disclosed data showing a drug Akeso discovered bested Merck & Co.s dominant immunotherapy Keytruda in a Phase 3 trial. Since then, the market values of Summit and a number of companies developing similar types of bispecific antibodies for cancer have climbed sharply. Akeso now has more than $1 billion in cash on hand. Ben FidlerMark Pruzanski, the former CEO of MASH drug developer Intercept Pharmaceuticals, is now chairman of another, Inventiva, just as the biotechnology firm receives $100 million or so in fresh funding. Inventiva announced Pruzanskis appointment Monday alongside news of the funding, which it will use to complete a Phase 3 trial of its experimental MASH medicine lanifibranor. New Enterprise Associates, BVF Partners and Samsara BioCapital led the financing, along with eight other new and existing investors. Inventiva could receive up to $277 million more in additional funding tranches. Ned Pagliarulo '