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AstraZeneca's (AZN) Imfinzi Misses Goal in Cervical Cancer Study

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AstraZeneca (AZN - Free Report) announced that the phase III CALLA study, which evaluated its PD-L1 inhibitor drug Imfinzi for cervical cancer indication, failed to achieve statistical significance in its primary endpoint.

The CALLA study evaluated a combination of Imfinzi and standard-of-care chemoradiotherapy (CRT) in patients with locally advanced cervical cancer. The study did not achieve its primary endpoint of improvement in progression-free survival (PFS) with statistical significance compared to CRT alone.

We remind investors that Imfinzi is AstraZeneca’s blockbuster oncology drug, which is already approved in the United States and marketed for two lung cancer indications. For the full year, AstraZeneca recorded $2.4 billion from Imfinzi sales.

Apart from the above indications, AZN is evaluating Imfinzi across many other oncology indications like liver cancer, bladder cancer and bilary tract cancer as part of a broad clinical development program. Data readouts from these ongoing clinical studies are expected later this year and in 2023.

Shares of AstraZeneca have rallied 13.3% this year so far compared with the industry’s 2.3% rise.

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AstraZeneca is highly focused on strengthening its oncology business. AZN generated $13.7 billion revenues from its Oncology business, accounting for 37% of its total 2021 revenues, driven by the solid performance of newer medicines, such as Tagrisso, Lynparza, Imfinzi and Calquence. AZN is working to further strengthening this portfolio through label expansions and progressing oncology pipeline candidates.

AstraZeneca’s Imfinzi faces stiff competition from other PD-1/PD-L1 inhibitor drugs, which are being marketed by pharma-giants like Bristol Myers (BMY - Free Report) and Merck (MRK - Free Report) . BMY markets Opdivo while MRK markets Keytruda.

Both Opdivo and Keytruda are blockbuster drugs that not only received the FDA approvals for use in multiple cancer indications (including lung cancer) but are also being evaluated for multiple cancer indications, both as a monotherapy and in combination studies. In fact, Merck’s Keytruda is also approved for two cervical cancer indications.

For 2021, Bristol Myers recorded revenues worth $7.5 billion from Opdivo product sales, while Merck generated $17.2 billion revenues from Keytruda sales.

In a separate press release, AstraZeneca also announced that its long-acting cocktail antibody therapy Evusheld is recommended for marketing authorization in the European Union for pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents aged 12 years and above with a weight of at least 40 kg. The therapy was already approved by the FDA for a similar indication in December 2021 and also received authorization for a similar use in Great Britain earlier this month.

Zacks Rank & Key Pick

AstraZeneca currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare space is Vertex Pharmaceuticals (VRTX - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 13.3% year to date.

Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.

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