AstraZeneca’s Tagrisso and Imfinzi helped patients live longer in separate pivotal clinical trials evaluating the drugs in two different types of lung cancer. The results will be presented Sunday during the annual meeting of the American Society of Clinical Oncology.
FDA approval of AstraZeneca’s Imjudo comes less than three weeks after the antibody won its first approval in liver cancer. Both regulatory decisions cover use of the drug in combination with another AstraZeneca immunotherapy, Imfinzi.
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AstraZeneca drug Imjudo is now FDA approved for treating advanced liver cancer. The infused therapy is administered under a novel dosing schedule in addition to Imfinzi, an AstraZeneca drug already approved for treating several different types of cancer.
AstraZeneca is withdrawing U.S. marketing of Imfinzi in bladder cancer after the drug failed a study required as a condition of its 2017 accelerated approval. The drug’s other approvals in lung cancer are not affected.
In this episode of MedCity Pivot podcast, we talk with Camille Hertzka, AstraZeneca's U.S. Head of Medical Affairs Oncology, about the clinical study findings on lung cancer presented at ESMO and the rapidly changing landscape for lung cancer treatment.
The drugmaker said Monday that the FDA had approved Imfinzi, its PD-L1 inhibitor, for first-line extensive-stage small cell lung cancer, with platinum chemotherapy. The drug creates a new competitive threat to Roche's Tecentriq, which is approved for the same disease setting.
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The FDA gave priority review to the British drugmaker's application for Imfinzi in first-line extensive-stage SCLC. Data published last month showed a statistically significant improvement in overall survival for the drug plus chemotherapy compared with chemotherapy alone.
The company said Imfinzi and chemotherapy, with or without tremelimumab, extended progression-free survival in first-line non-small cell lung cancer versus chemotherapy, setting up Imfinzi as a potential competitor to Merck's Keytruda. Overall survival data are expected next year.
Data for AstraZeneca's Imfinzi showed an improvement in overall survival and duration of response in patients with first-line extensive-stage small-cell lung cancer. Roche's Tecentriq already has approval in that indication.
The company said Wednesday that the pairing of PD-L1 inhibitor Imfinzi and CTLA-4 inhibitor tremelimumab did not prolong overall survival in previously untreated metastatic non-small cell lung cancer. The Phase III results are the latest in a string of failures for the combination.
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The company also advanced a therapy, a personalized cancer vaccine in melanoma, into a Phase II study as the first patient in the trial consented.
The company said the Phase III CASPIAN study of Imfinzi in first-line, extensive-stage small-cell lung cancer was successful, but did not disclose further details. Roche's Tecentriq is already approved for that indication, which accounts for two-thirds of SCLC cases.
The studies - in lung and head and neck cancers - produced negative results late last year. Several Phase I Imfinzi and tremelimumab studies were also removed, but others were added to the company's pipeline.
The company pointed to better survival numbers in patients with high tumor mutational burden, in a presentation at the ESMO immuno-oncology congress in Geneva.
Results of the Phase III EAGLE study leave Merck's Keytruda and Bristol's Opdivo as the dominant players in the space of HNSCC after progression on platinum-based chemotherapy.