Imfinzi growth prospects
AstraZeneca is confident of the potential of its immuno-oncology portfolio in treating the majority of NSCLC (non-small cell lung cancer) patients without EGFR (epidermal growth factor receptor) mutations. Most of these patients are not eligible for surgery, so they directly opt for chemoradiation. To date, there are no other treatment options for these patients. However, on May 12, 2017, AstraZeneca announced positive results from its Phase 3 trial PACIFIC based on an interim analysis by the Independent Data Monitoring Committee. The company’s oncology drug Imfinzi managed to meet its primary endpoint compared to a placebo, highlighting the drug’s efficacy profile as a maintenance therapy for patients suffering with locally advanced, unresectable NSCLC when the disease did not progress after chemoradiation therapy.
If Imfinzi secures regulatory approval for this indication, it may have a favorable impact on AstraZeneca stock as well as the stock of the Vanguard FTSE Developed Markets ETF (VEA). AstraZeneca makes up about 0.21% of VEA’s total portfolio holdings.
Ongoing research programs
Currently, AstraZeneca is exploring the efficacy of Imfinzi in early stage NSCLC in an adjuvant setting. Imfinzi is also being tested as a monotherapy as well as in combination with tremelimumab compared to the standard of care chemotherapy in its MYSTIC trial to evaluate the efficacy of AstraZeneca’s immuno-oncology therapies as a first line treatment for EGFR and ALK (anaplastic lymphoma kinase) wild-type metastatic NSCLC.
Originally focused solely on PFS (progression-free survival), AstraZeneca modified the trial design to have both PFS and overall survival as primary endpoints. Further, the company will study the efficacy of its investigational therapies, both in patients expressing PD-L1 and for “all comers” (all patients fulfilling the eligibility criteria for the trial). Data from the MYSTIC trial are expected by mid-2017. If the data are positive, it will be a major milestone for the company, enabling it to compete effectively with other NSCLC-focused immuno-oncology players such as Bristol-Myers Squibb (BMY), Merck & Co. (MRK), and Roche Holdings (RHHBY).