AstraZeneca plc’s AZN late-stage study evaluating its PD-L1 inhibitor Imfinzi for the first line treatment of certain lung cancer patients failed to meet the primary endpoint.
The phase III NEPTUNE study was evaluating Imfinzi in combination with tremelimumab for the treatment of stage IV non-small cell lung cancer (NSCLC) versus standard-of-care (SoC) platinum-based chemotherapy. The primary analysis population of the study was patients with a high tumor mutational burden (TMB). In patients whose blood TMB was 20 or more mutations per megabase, the Imfinzi combo failed to improve overall survival – the primary endpoint - versus SoC. AstraZeneca said it will submit data from the study at a future medical meeting.
For stage IV NSCLC, Imfinzi is also being studied as monotherapy in the phase III PEARL study and in combination with chemotherapy with or without tremelimumab in the phase III POSEIDON study.
Shares of AstraZeneca have rallied 17.4% this year so far against the industry’s decrease of 1.5%.
Imfinzi Is presently marketed as a monotherapy for patients with locally-advanced, unresectable (stage III) NSCLC, whose disease has not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT). Other than the lung cancer indication, Imfinzi is also marketed for second-line advanced bladder cancer.
Imfinzi recorded sales of $633 million in the first half of 2019 mainly driven by strong demand in lung cancer patients. A large portion of Imfinzi’s sales comes from the United States and the lung cancer indication. Imfinzi (durvalumab) is also being evaluated for multiple other cancers (either alone or in combination with other regimens) and has bright long-term prospects.
The demand for checkpoint inhibitors, especially those targeting PD-1 and PD-L1, has risen significantly in the past couple of years. It is estimated that their market will rise tremendously in the next four to five years. PD-1 and PD-L1 are proteins present on the surface of cancer cells. Other PD-L1 inhibitors on the market are Merck’s MRK Keytruda, Bristol Myers’ BMY Opdivo, Roche’s Tecentriq and Pfizer’s PFE Bavencio.
In a separate press release, AstraZeneca announced that its SGLT2 inhibitor, Farxiga met the primary endpoint in a heart failure outcomes study in patients with reduced ejection fraction with and without type-II diabetes.
Data from the phase III DAPA-HF study showed that Farxiga when added to standard of care led to a statistically-significant and clinically-meaningful reduction of cardiovascular death or worsening of heart failure in such patients compared to placebo, thereby meeting the study’s primary endpoint.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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