AstraZeneca AZN announced that the FDA expanded the label of its blockbuster cancer drug Imfinzi for a fourth indication in lung cancer.
The FDA approved Imfinzi in combination with platinum-based chemotherapy for treating adults with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) with no known EGFR mutations or ALK rearrangements. While the Imfinzi-chemotherapy combo will be administered before surgery, Imfinzi monotherapy will be given after surgery.
This approval is based on data from the phase III AEGEAN study, which showed that treatment with an Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% in resectable early-stage NSCLC patients compared with chemotherapy alone.
Imfinzi is already approved for a similar indication in the U.K., Switzerland and Taiwan based on data from the AEGEAN study. A regulatory filing is currently under review in the European Union and China.
Imfinzi is already approved in the U.S. for three lung cancer indications — two in NSCLC (across different settings) and one in extensive-stage small cell lung cancer (ES-SCLC). Apart from lung cancer, the drug is also approved in the country for biliary tract cancer, endometrial cancer and hepatocellular carcinoma (HCC) indications.
AstraZeneca’s shares have risen 26.0% year to date compared with the industry’s 24.8% growth.
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Imfinzi is a key revenue driver for AZN’s oncology portfolio, having generated sales worth $2.26 billion in the first half of 2024, up 25% year over year at constant exchange rates. The demand for the drug is being driven by increased use in recent launches like biliary tract and HCC cancers and rising patient demand across lung cancer indications.
The drug is also being studied for multiple cancer indications, either alone or in combination with other regimens, including phase III studies in earlier settings in lung cancer, early-stage gastric and gastroesophageal junction cancer and liver cancer, among others.
In a separate press release, the company announced that the FDA has accepted a regulatory filing seeking label expansion for Imfinzi in patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based concurrent chemoradiotherapy. The agency has granted a priority review to this filing and a final decision is expected before 2024-end. Alongside this information, the company also announced that the agency recently granted breakthrough therapy designation to the drug in this setting.
The above filing is based on data from the late-stage ADRIATIC study, which showed that treatment with Imfinzi achieved statistically significant and clinically meaningful benefits in overall survival and progression-free survival endpoints.
This is the second regulatory label expansion for Imfinzi this week. The European Commission approved a combination therapy of Imfinzi and Lynparza to treat certain patients with primary advanced or recurrent endometrial cancer. This approval is based on data from the late-stage DUO-E study, which showed that the Imfinzi-Lynparza combo reduced the risk of disease progression or death by 43% compared with the control arm.
Per management, the EU approval of the Imfinzi and Lynparza regimens is a milestone achievement for the company as it marks the first-ever approval for a combination of an immunotherapy and PARP inhibitor in endometrial cancer.
Like Imfinzi, Lynparza is also a key generator of revenue for AstraZeneca adding $1.45 billion to its topline during first-half 2024, up 9% year over year at constant exchange rates. This drug is marketed in partnership with Merck MRK.
AstraZeneca and Merck formed a profit-sharing deal to co-market Lynparza and Koselugo in 2017. The Merck-partnered Lynparza is approved for four cancer types such as ovarian, breast, prostate and pancreatic.
AstraZeneca is focused on strengthening its oncology business through label expansions of existing products and progressing oncology pipeline candidates. Oncology sales now comprise around 40% of AstraZeneca‘s total revenues and rose 17% in 2021, 19% in 2022 and 21% in 2023. This strong oncology performance was driven by medicines such as Tagrisso, Lynparza, Imfinzi, Calquence, and Enhertu (in partnership with Daiichi Sankyo). Management intends to develop a treatment for every form of cancer.
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Zacks Rank & Key Picks
AstraZeneca currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Arcturus Therapeutics ARCT and Fulcrum Therapeutics FULC, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Arcturus Therapeutics’ 2024 loss per share have improved from $4.39 to $2.60. Estimates for 2025 have improved from a loss of 45 cents to earnings of 21 cents per share during the same period. Year to date, shares of Arcturus Therapeutics have lost 35.8%.
Earnings of Arcturus Therapeutics beat estimates in each of the last four quarters. Arcturus delivered a four-quarter average earnings surprise of 56.73%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 during the same period. Year to date, shares of Fulcrum Therapeutics have surged 43.6%.
Earnings of Fulcrum Therapeutics beat estimates in each of the last four quarters. Fulcrum delivered a four-quarter average earnings surprise of 393.18%.
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