AstraZeneca AZN announced that the FDA has approved its blockbuster cancer drug Imfinzi (durvalumab) for treating limited-stage small cell lung cancer (LS-SCLC) in adult patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Following the latest nod, Imfinzi became the first and only immunotherapy regimen approved for treating LS-SCLC. In August, the FDA accepted and granted a priority review to AZN’s regulatory filing seeking label expansion for Imfinzi in patients with LS-SCLC.

The FDA had also granted a breakthrough therapy designation to Imfinzi in this setting.

Regulatory applications seeking approval for Imfinzi in LS-SCLC are currently under review in the EU, Japan and several other countries.

Year to date, shares of AstraZeneca have decreased 0.9% against the industry’s increase of 9.3%.

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Latest Approval for Imfinzi Based on AZN's ADRIATIC Study

The approval for the expanded use of Imfinzi was based on data from the phase III ADRIATIC study.

Data from the phase III ADRIATIC study showed that treatment with Imfinzi reduced the risk of death by 27% as compared to placebo.

The estimated median overall survival was 55.9 months following treatment with Imfinzi compared to 33.4 months for patients treated with a placebo. Around 57% of patients treated with Imfinzi were alive at three years versus 48% for those treated with placebo.

Additionally, treatment with Imfinzi reduced the risk of disease progression or death by 24% versus placebo.

The safety profile of Imfinzi was similar to the known profile of the drug. No new safety signals were reported in the given setting.

Imfinzi: A Key Revenue Driver for AZN

Imfinzi is the global standard of care in the curative-intent setting of unresectable, stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy. It is also approved for extensive-stage- small cell lung cancer, locally advanced or metastatic biliary tract cancer, and endometrial cancer that is mismatch repair deficient and in combination with Imjudo in unresectable hepatocellular carcinoma in some countries.

Imfinzi is a key revenue driver for AZN’s oncology portfolio, having generated sales worth $3.46 billion in the first nine months of 2024, up 22% year over year at constant exchange rates, driven by demand growth across all approved indications.

Imfinzi is being evaluated for multiple cancers, either alone or in combination with other regimens, including phase III studies in earlier settings in NSCLC, early-stage gastric and gastroesophageal junction cancer, muscle-invasive bladder cancer and liver cancer, among others.

AZN's Zacks & Key Picks

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

Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 53.6%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Loss per share estimates for 2025 have narrowed from $1.54 to 79 cents during the same time. Year to date, shares of SPRO have declined 19.7%.

SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 47.6%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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