AstraZeneca Imfinzi Combo Gets EU Nod for Uterine Cancer

AstraZeneca AZN announced that the combination therapy of its PD-L1 inhibitor, Imfinzi (durvalumab), and PARP inhibitor, Lynparza (olaparib), has been approved in the EU to treat certain patients with primary advanced or recurrent endometrial cancer, also known as uterine cancer.

The eligible patient population for receiving Imfinzi plus chemotherapy as a first-line treatment followed by Lynparza and Imfinzi are patients with mismatch repair proficient (pMMR) disease. For those who suffer from mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer, Imfinzi plus chemotherapy followed by Imfinzi monotherapy has also been approved in the EU.

The final decision in the EU follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in July 2024, recommending the approval for the Lynparza and Imfinzi combination to treat patients with pMMR advanced or recurrent endometrial cancer. The CHMP had also recommended Imfinzi plus chemotherapy followed by Imfinzi alone for patients with dMMR advanced or recurrent endometrial cancer.

The approval of both regimens in the EU was based on data from a prespecified exploratory subgroup analysis by MMR status in the phase III DUO-E study.

Data from the DUO-E study showed that the Lynparza plus Imfinzi combo reduced the risk of disease progression or death by 43% in pMMR patients compared with the control arm. Meanwhile, the Imfinzi plus chemotherapy 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 24.4% year to date compared with the industry's growth of 22.9%.

Image Source: Zacks Investment Research

Per management, the 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.

Per AstraZeneca, endometrial cancer is the fourth most common cancer in women in the EU. Approximately, 70% to 80% of such endometrial cancer patients have mismatch repair proficient disease with few available treatment options, representing a huge unmet medical need.

Imfinzi plus chemotherapy, followed by Imfinzi monotherapy, was approved for treating adult patients with dMMR advanced or recurrent endometrial cancer based on data from the DUO-E study in the United States in June.

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 $2.26 billion in the first half of 2024, up 25% year over year at constant exchange rates. During the same period, Lynparza product revenues rose 9% year over year at constant exchange rates to $1.45 billion.

We remind the investors 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. AZN and MRK's Lynparza is approved for four cancer types, such as ovarian, breast, prostate and pancreatic.

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

Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the overall healthcare sector are Entrada Therapeutics TRDA and Immatics IMTX. While TRDA sports a Zacks Rank #1 (Strong Buy), IMTX carries a Zacks Rank #2 (Buy) at present.

In the past 60 days, the Zacks Consensus Estimate for Entrada Therapeutics' 2024 loss per share has narrowed from 34 cents to 13 cents. The consensus estimate for 2025 loss per share has narrowed from $4.06 to $3.21 during the same period. Year to date, shares of TRDA have gained 4.8%.

Entrada Therapeutics beat earnings estimates in three of the last four quarters and missed once, delivering an average earnings surprise of 97.14%.

In the past 60 days, the consensus mark for Immatics' loss per share has narrowed from $1.26 to $1.25 for 2024. During the same period, the Zacks Consensus Estimate for 2025 loss per share has narrowed from $1.49 to $1.41. Year to date, shares of IMTX have gained 11.2%.

Immatics beat earnings estimates in each of the last four quarters, delivering an average earnings surprise of 45.45%.

To read this article on Zacks.com click here.