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AstraZeneca's (AZN) Imfinzi Early-Stage Lung Cancer Study Fails
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AstraZeneca (AZN - Free Report) announced that a phase III study evaluating Imfinzi for an early stage of non-small cell lung cancer (NSCLC) failed to reach statistical significance for the primary endpoint.
The phase III study called PACIFIC-2 evaluated Imfinzi concurrently administered with platinum-based chemoradiotherapy (CRT) versus CRT alone in unresectable, stage III NSCLC.
At present, Imfinzi sequentially administered after platinum-based CRT is approved for the treatment of unresectable, stage III NSCLC based on data from the PACIFIC phase III study. The PACIFIC-2 study was initiated with the aim of concurrent Imfinzi administration with CRT for patients who progress or discontinue treatment during CRT, and so become ineligible for the PACIFIC regimen.
However, the PACIFIC -2 study did not achieve statistical significance for the primary endpoint of progression-free survival (PFS).
Year to date, the stock has decreased 5.3% against the industry’s 3.9% rise.
Image Source: Zacks Investment Research
Imfinzi generated sales of $3.1 billion in the first nine months of 2023, up 56% year over year, driven by increased use in recent launches like Stage IV NSCLC, biliary tract and hepatocellular carcinoma cancers and stable growth in established indication like SCLC and Stage III NSCLC. Product sales from Imjudo, which was launched in 2022 for unresectable liver cancer and stage IV NSCLC, are included in the Imfinzi line. Imfinzi revenues in the first nine months of 2023 included $161 million in revenues from Imjudo.
Imfinzi is being evaluated for multiple cancers, either alone or in combination with other regimens, including phase III trials in earlier settings in NSCLC and SCLC, early- stage gastric and gastroesophageal junction cancer and liver cancer among others.
In a separate press release, AstraZeneca announced that China’s National Medical Products Administration has approved Imfinzi for the first-line treatment of locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine and cisplatin). The approval is based on data from the TOPAZ-1 global phase III study and an additional cohort of patients in China. Imfinzi plus chemotherapy is already approved in the United States, EU and Japan for the said BTC indication.
Zacks Rank & Stocks to Consider
Currently, AstraZeneca has a Zacks Rank #3 (Hold).
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.62 over the past 30 days. Estimates for 2024 have jumped from $2.95 per share to $3.07 over the same timeframe. NVO’s stock has surged 46.6% year to date.
In the past 30 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 23 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 3 cents to 18 cents. Year to date, shares of DVAX have rallied 29.7%.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have been stable at $4.89. During the same period, loss per share estimates for 2024 have been stable at $4.02. Year to date, shares of MEIP have rallied 49.3%.
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AstraZeneca's (AZN) Imfinzi Early-Stage Lung Cancer Study Fails
AstraZeneca (AZN - Free Report) announced that a phase III study evaluating Imfinzi for an early stage of non-small cell lung cancer (NSCLC) failed to reach statistical significance for the primary endpoint.
The phase III study called PACIFIC-2 evaluated Imfinzi concurrently administered with platinum-based chemoradiotherapy (CRT) versus CRT alone in unresectable, stage III NSCLC.
At present, Imfinzi sequentially administered after platinum-based CRT is approved for the treatment of unresectable, stage III NSCLC based on data from the PACIFIC phase III study. The PACIFIC-2 study was initiated with the aim of concurrent Imfinzi administration with CRT for patients who progress or discontinue treatment during CRT, and so become ineligible for the PACIFIC regimen.
However, the PACIFIC -2 study did not achieve statistical significance for the primary endpoint of progression-free survival (PFS).
Year to date, the stock has decreased 5.3% against the industry’s 3.9% rise.
Image Source: Zacks Investment Research
Imfinzi generated sales of $3.1 billion in the first nine months of 2023, up 56% year over year, driven by increased use in recent launches like Stage IV NSCLC, biliary tract and hepatocellular carcinoma cancers and stable growth in established indication like SCLC and Stage III NSCLC. Product sales from Imjudo, which was launched in 2022 for unresectable liver cancer and stage IV NSCLC, are included in the Imfinzi line. Imfinzi revenues in the first nine months of 2023 included $161 million in revenues from Imjudo.
Imfinzi is being evaluated for multiple cancers, either alone or in combination with other regimens, including phase III trials in earlier settings in NSCLC and SCLC, early- stage gastric and gastroesophageal junction cancer and liver cancer among others.
In a separate press release, AstraZeneca announced that China’s National Medical Products Administration has approved Imfinzi for the first-line treatment of locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine and cisplatin). The approval is based on data from the TOPAZ-1 global phase III study and an additional cohort of patients in China. Imfinzi plus chemotherapy is already approved in the United States, EU and Japan for the said BTC indication.
Zacks Rank & Stocks to Consider
Currently, AstraZeneca has a Zacks Rank #3 (Hold).
AstraZeneca PLC Price and Consensus
AstraZeneca PLC price-consensus-chart | AstraZeneca PLC Quote
Some better-ranked stocks in the drug/biotech sector are Novo Nordisk (NVO - Free Report) , Dynavax Technologies Corporation (DVAX - Free Report) and MEI Pharma, Inc. (MEIP - Free Report) . While Dynavax Technologies and MEI Pharma sport a Zacks Rank #1 (Strong Buy) each, Novo Nordisk carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.62 over the past 30 days. Estimates for 2024 have jumped from $2.95 per share to $3.07 over the same timeframe. NVO’s stock has surged 46.6% year to date.
In the past 30 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 23 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 3 cents to 18 cents. Year to date, shares of DVAX have rallied 29.7%.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have been stable at $4.89. During the same period, loss per share estimates for 2024 have been stable at $4.02. Year to date, shares of MEIP have rallied 49.3%.