AstraZeneca's cancer combo wins second nod in one month, this time in lung cancer
Weeks after celebrating the first cancer win for its Imfinzi and Imjudo duo, AstraZeneca is once again breaking out the party hats.
The monoclonal antibody combo scored a label expansion on Thursday in metastatic non-small cell lung cancer (NSCLC) alongside platinum-based chemotherapy. Just last month, the drugs won a nod in unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.
AstraZeneca spent years searching for the right dosing regimen for Imjudo before it was finally approved just last month, joining Bristol Myers Squibb’s Yervoy as the only FDA-cleared CTLA-4 drugs. The new indication gives Imfinzi and Imjudo access to a major — but crowded — market.
Lung cancer is the second most commonly diagnosed type in the US, according to AstraZeneca, and NSCLC carries a particularly poor prognosis. However, Merck’s multibillion dollar PD-1 therapy Keytruda has a tight grip on the market, and other rivals such as Bristol Myers Squibb’s Opdivo and Roche’s Tecentriq put up a tough fight.
Earlier this week, Regeneron’s PD-(L) inhibitor Libtayo won approval in combination with chemotherapy as a frontline treatment for adult patients with advanced non-small cell lung cancer with no EGFR, ALK or ROS1 aberrations.
Imfinzi and Imjudo are approved to treat metastatic NSCLC patients who have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Imjudo was licensed to AstraZeneca by Pfizer in 2011, following some disappointing early results. While AstraZeneca has since posted its own fair share of flops, the latest approval is based on data from the successful POSEIDON trial, which showed that Imfinzi and Imjudo combined with chemo and maintenance therapy achieved a median overall survival of 14 months compared to 11.7 months in patients on chemotherapy alone followed by maintenance therapy (p= 0.00304). Median progression-free survival was 6.2 months and 4.8 months, respectively (p= 0.00031).
The most common adverse events were nausea, fatigue, decreased appetite, musculoskeletal pain, rash and diarrhea, according to the FDA.
“This approval underscores the importance of delivering novel treatment combinations that extend survival in metastatic non-small cell lung cancer, a complex setting where many patients still face a dismal prognosis,” Dave Fredrickson, executive VP of AstraZeneca’s oncology business unit, said in a statement. The company was not immediately available for an interview.
AstraZeneca says it’s still waiting to hear from regulators in Europe, Japan and other countries.