Novartis shelves a PD-1 bid in non-small cell lung cancer after FDA feedback

Shortly after the FDA delayed a decision for Novartis and BeiGene’s tislelizumab in previously treated esophageal squamous cell carcinoma (ESCC), the company is scrapping the drug's U.S. submission as a monotherapy for non-small cell lung cancer (NSCLC).

Novartis ditched the monotherapy filing in newly diagnosed NSCLC after hearing feedback from the FDA, the company said Tuesday.

On Novartis’ second-quarter conference call, CEO Vas Narasimhan said that the FDA’s assessment of the data set was that it “didn’t adequately reflect the U.S. population in terms of the number of patients and the standard of care that was used in that BeiGene-driven first-line study." The FDA is making it clear that filed studies must be “global in nature, have an appropriate amount of U.S. patients, and that the standard of care used reflects standard of care in the U.S.," the CEO added. 

Now, company’s focus is to finish the filing in previously treated esophageal cancer, Narasimhan said. He also touted a potential filing in first-line esophageal cancer.

The FDA's emphasis on trial diversity for PD-1/L1 contenders started with a recent rejection of Eli Lilly and Innovent Biologics' Tyvyt (sintilimab), also in newly diagnosed NSCLC.

Currently, most patients newly diagnosed with metastatic NSCLC get the combination of a PD-1/L1 inhibitor alongside chemotherapy rather than a single-agent immunotherapy. Merck's Keytruda boasts a monotherapy approval in patients whose tumors express the PD-L1 biomarker, and Roche's Tecentriq also has a monotherapy label but in a PD-L1-high population.

Novartis gained rights to tislelizumab in major markets outside China by doling out $650 million upfront to BeiGene and committing up to $1.55 billion in milestones early last year. Novartis called tislelizumab “complementary” to its checkpoint inhibiter spartalizumab and said it could play a key role in its PD-1/L1 combination strategy.

Tislelizumab won approval in China in 2019 as a third-line treatment for classical Hodgkin lymphoma.

Novartis' scrapped FDA filing comes right on the heels of another regulatory setback for the drug. Last week, the company disclosed the delay in previously treated ESCC because COVID-related travel restrictions hindered the FDA from performing manufacturing inspections in China.