AstraZeneca (AZN) Imfinzi Combo Gets CHMP Nod for Expanded Use

Zacks Equity Research
·4-min read

AstraZeneca AZN announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its PD-L1 inhibitor Imfinzi (durvalumab) as a treatment for certain patients with primary advanced or recurrent endometrial cancer.

The CHMP recommended the approval of Imfinzi plus chemotherapy, followed by Imfinzi and Lynparza as a first-line treatment for patients with mismatch repair proficient (pMMR) advanced or recurrent endometrial cancer.

The CHMP has also recommended the approval of Imfinzi plus chemotherapy, followed by Imfinzi monotherapy for the treatment of patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer.

The CHMP’s positive opinion of both regimens was based on data from a prespecified exploratory subgroup analysis by MMR status in the phase III DUO-E study.

Data from the Lynparza plus Imfinzi arm showed a reduction in the risk of disease progression or death by 43% in pMMR patients versus the control arm. Meanwhile, the Imfinzi arm showed a reduction in the risk of disease progression or death by 58% for dMMR patients compared with the control arm.

Importantly, the safety profiles of both regimens were manageable and well-tolerated.

Shares of AstraZeneca have gained 15.8% year to date compared with the industry’s rally of 21.1%.

Last month, the FDA approved Imfinzi plus chemotherapy, followed by Imfinzi monotherapy for treating adult patients with dMMR advanced or recurrent endometrial cancer based on data from the phase III DUO-E study.

Regulatory applications seeking approval for Imfinzi plus Lynparza regimen are currently under review in Japan and other countries to include data from the DUO-E study on Imfinzi’s label.

Both Imfinzi and Lynparza are key revenue drivers of AZN’s oncology portfolio. Imfinzi generated sales worth $1.11 billion in the first quarter of 2024, which was 33% up year over year at constant exchange rates. Lynparza product revenues rose 11% year over year at constant exchange rates to $705 million.

Please note that AstraZeneca markets Lynparza in partnership with Merck MRK.

AstraZeneca and Merck formed a profit-sharing deal to co-market Lynparza and Koselugo in 2017. AstraZeneca and Merck’s Lynparza is approved for four cancer types, ovarian, breast, prostate and pancreatic.

Lynparza is also being evaluated in combination with MRK’s Keytruda in late-stage studies for lung cancer indications.

In a separate press release, AZN announced that the EMA has accepted its marketing authorization application (MAA) seeking approval for sipavibart to prevent COVID-19 under accelerated assessment.

Sipavibart is an investigational long-acting antibody that is being developed to prevent COVID-19 in immunocompromised patients. The accelerated assessment helps in reducing the timeline for the CHMP to review the MAA compared to the standard procedure.

The MAA for sipavibart was based on positive data from the phase III SUPERNOVA study. Data from the same showed that treatment with sipavibart led to a statistically significant reduction in the incidence of COVID-19 in an immunocompromised patient population.

AstraZeneca is currently working with other regulatory authorities for the potential authorization or approval for sipavibart.

Zacks Rank & Stocks to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector are Acrivon Therapeutics, Inc. ACRV and Aligos Therapeutics, Inc. ALGS, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.05 to $2.47. Loss per share estimates for 2025 have narrowed from $3.04 to $2.55. Year to date, ACRV shares have rallied 17.8%.

ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining one occasion, the average surprise being 3.56%.

In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, ALGS shares have declined 44.3%.

ALGS’ earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 7.83%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

AstraZeneca PLC (AZN) : Free Stock Analysis Report

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