AstraZeneca’s Imfinzi Shows Positive Overall Survival Results in Lung Cancer Trial
AstraZeneca and its research-and-development unit MedImmune, announced positive overall survival (OS) data for its Phase III PACIFIC trial of Imfinzi (durvalumab) in patients with unresectable Stage III non-small cell lung cancer (NSCLC).
The patient population has NSCLC whose disease had not progressed after platinum-based chemotherapy and radiation therapy. An interim analysis by an Independent Data Monitoring Committee decided the trial had met its second of two primary endpoints—statistically-significant OS benefit with clinically-meaningful improvement in patients on Imfinzi compared to placebo.
“The readout of positive overall survival data at the interim analysis of the PACIFIC trial provides additional compelling evidence of the clinical benefit that Imfinzi can offer patients in this earlier stage of lung cancer,” said Sean Bohen, AstraZeneca’s executive vice president, Global Medicines Development, and chief medical officer, in a statement. “We look forward to sharing these results with Health Authorities to support ongoing regulatory interactions and to update the Imfinzi label with these important data.”
Imfinzi is a human monoclonal antibody that binds to PD-L1, blocking the interaction of PD-L1 with PD-1 and CD80. The drug received approval in Canada earlier this month for patients with unresectable Stage III NSCLC after chemoradiation therapy (CRT). In February, the U.S. Food and Drug Administration (FDA) granted the drug approval for patients with unresectable Stage III NSCLC who had not progressed after concurrent platinum-based CRT.
The drug is being tested as a monotherapy and in combination with chemotherapy radiation therapy, small molecules, and an anti-CTLA4 monoclonal antibody called tremelimumab as a possible first-line treatment for NSCLC, small cell lung cancer, locally-advanced or metastatic urothelial cancer, head and neck cancer and other solid tumors.
The results here will help AstraZeneca stay in the competition with Merck and Bristol-Myers Squibb, both battling to offer the drug-of-choice for front-line lung cancer. Only a couple days ago, Dave Fredrickson, head of AstraZeneca’s oncology business unit, told investors, “This has resulted in a true inflection point for Imfinzi with sales now at $62 million in the first quarter and really the overwhelming majority of these coming from the lung cancer indication. As you saw from a slide that Pascal [Soriot, company chief executive officer] showed in February when we launched, we had about 3,500 patient infusions per month and you could see that we’ve now doubled in the most recent month to 7,000 patient infusions per month, really showing that the underlying patient demand is the driver of these sales.”
The data presented late last year indicated that patients receiving Imfinzi lived 16.8 months longer on average without their disease getting worse, compared to 5.6 months for patients on placebo. That led to FDA approval in February for NSCLC patients with inoperable mid-stage disease that had not metastasized. It was the first immunotherapy to be approved in that setting.
CNBC reports, “That distinguishes it from rivals Merck, Bristol-Myers Squibb and Roche that beat the British drugmaker in winning approval for similar immunotherapies in advanced or metastatic disease. Analysts believe using Imfinzi in stage III lung cancer, where cancer has only spread locally, opens up a multibillion-dollar sales opportunity and the latest overall survival (OS) data should underline the drug’s potential.”
Analysts with Berenberg wrote in a note to investors, “Consensus has peak Imfinzi sales at $2.8 billion by 2023 and the achievement of an OS benefit may not result in much of a change in sales expectations. Nevertheless … the OS data will help Astra in its physician education and ensure the peak sales can be achieved.”
The company indicated it will publish full details at an upcoming medical conference.