AstraZeneca, plc (AZN - Free Report) announced data from a late-stage study on Imfinzi which showed that the new cancer drug led to superior progression-free survival to standard of care in lung cancer patients. Shares of AstraZeneca inched up more than 1% on Friday as well as in pre-market trading on Monday.
So far this year, AstraZeneca’s shares have moved up 18% comparing favorably with the industry’s 14.8% increase.
Interim data from the phase III PACIFIC trial study showed that treatment with Imfinzi improved PFS by more than 11 months in comparison to standard of care in patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) who have not progressed following chemoradiation. The median PFS was 16.8 months for patients on Imfinzi compared with 10.2 months in the comparator arm.
Presented at the European Society of Medical Oncology Congress (ESMO) in Madrid, the data was also published online in the New England Journal of Medicine. We remind investors that earlier in July, a Breakthrough Therapy designation was granted to Imfinzi for this indication.
AstraZeneca claims that Imfinzi is the first medicine to have demonstrated superior PFS in the concerned patient population, which was til now left unattended for want of proper treatment options.
The PACIFIC study continues to evaluate the other primary endpoint, overall survival (OS).
In a separate press release, AstraZeneca announced full results of the phase III FLAURA study, evaluating another lung cancer drug, Tagrisso, in the first line setting. Disclosed data showed that treatment with Tagrisso reduced the risk of progression or death by more than half compared with other commonly-used EGFR inhibitors for the first-line treatment of patients with EGFR mutation-positive NSCLC.
The median PFS was 18.9 months for patients on Tagrisso as compared to 10.2 months in the comparator arm. Good news is that consistent benefit was observed across all subgroups, including patients with and without brain metastases. This significant data was also presented at ESMO.
Notably, the positive lung cancer finds come as a huge relief post the failure of thepivotal first-line lung cancer study, MYSTIC, on Imfinzi.
In July, AstraZeneca’s share price plunged sharply after it announced that the MYSTIC study on Imfinzi failed to show benefit on progression-free-survival. The failure to show PFS benefit brought into question MYSTIC’s ability to show an OS benefit. Final OS data from MYSTICare expected during the first half of 2018.
Imfinzi (durvalumab) is presently marketed in the U.S. for one indication -- second line advanced bladder cancer -- since May this year. Meanwhile, Imfinzi is being evaluated for multiple cancers (either alone or in combination with other regimens), including phase III trials in first-line urothelial cancer, NSCLC, small cell lung cancer and head and neck squamous cell carcinoma (HNSCC) among others.
AstraZeneca is working on strengthening its oncology product portfolio and has several candidates in its pipeline. The immuno-oncology therapeutic area is presently attracting a lot of interest and represents huge commercial potential.Other phase III oncology candidates in AstraZeneca’s pipeline include acalabrutinib (blood cancers – under priority review in U.S.), moxetumomab pasudotox (leukaemia), selumetinib (thyroid cancer) and savolitinib (kidney cancer).
Lynparza, presently marketed for advanced ovarian cancerin partnership with Merck & Co, Inc. (MRK - Free Report) , is also in different studies for a range of tumor types including breast, prostate and pancreatic cancers as well as earlier-line settings for ovarian cancer. Tagrisso is also being evaluated in earlier-line settings for lung cancer.
AstraZeneca currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Better-ranked biotech stocks include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , both with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of Alexion are up 15.4% year to date. Its estimates for 2017 and 2018 have risen 5.5% and 6%, respectively over the past 60 days.
Regeneron’s shares up 28.4% this year so far. Estimates have risen 16.8% for 2017 while that for 2018 have gone up by 8.1% over the past 60 days.
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