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AstraZeneca's (AZN) Imfinzi/Imjudo Combo Gets Another FDA Nod
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AstraZeneca (AZN - Free Report) announced that the FDA approveda dual immunotherapy regimen consisting of PD-L1 inhibitor Imfinzi (durvalumab) and CTLA-4 antibody Imjudo (tremelimumab). The candidate is combined with platinum-based chemotherapy for treating adult patients with Stage IV (metastatic) non-small cell lung cancer (“NSCLC”).
Per management, lung cancer is the second most common form of cancer across the world. Out of this, 80-85% of patients are classified as NSCLC. Once the NSCLC metastasizes, patient’s treatment does not respond well to standard therapies. AstraZeneca believes that a checkpoint inhibitor like Imfinzi combined with a limited course of CTLA-4 inhibition by Imjudo benefits patients in the long term.
This FDA approval of the Imfinzi+Imjudo combo is based on data from the phase III POSEIDON study, which evaluated the above combination as a first-line treatment of patients with metastatic NSCLC, irrespective of non-squamous or squamous disease. Data from the study showed that participants who received this combination exhibited a 23% reduction in the risk of death compared with those who received a wide range of chemotherapy options. Data from a four-year follow-up of patients also showed that the combination improved overall survival (OS) by 25% compared with chemotherapy alone.
Shares of AstraZeneca have gained 7.8% this year compared with the industry’s 2.9% rise.
Image Source: Zacks Investment Research
Imfinzi is already approved for multiple cancer indications. It is already approved for Stage III NSCLC patients following chemotherapy. It is approved for extensive-stage small cell lung cancer (ES-SCLC) and biliary tract cancer (BTC) indications. Last month, the combination of Imfinzi and Imjudo was approved by the FDA for treating unresectable hepatocellular carcinoma (uHCC) in adult patients.
AstraZeneca also filed regulatory applications seeking approval for the combination of Imfinzi, Imjudo and chemotherapy in NSCLC in Europe, Japan and several other countries currently under review.
AstraZeneca’s Imfinzi competes for market share with Keytruda, also a PD-1/PD-L1 inhibitor, developed by Merck (MRK - Free Report) . Merck’s Keytruda has been approved for the treatment of multiple cancer indications worldwide, including NSCLC. In the United States alone, Merck received approval for Keytruda in four NSCLC indications.
In the first nine months of 2022, Merck recorded $15.5 billion in sales from Keytruda. Sales of Keytruda continue to grow, driven by continued uptake in lung cancer and increasing usage in other cancer indications.
In a separate press release, AstraZeneca also announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the combination of Imfinzi plus chemotherapy as a treatment of unresectable or metastatic BTC in adult patients. The CHMP opinion is based on positive data from the phase III TOPAZ-1 study, which showed that the Imfinzi-chemotherapy combination reduced the risk of death by 24% compared with chemotherapy alone. This combination was approved by the FDA for a similar indication this September.
Bayer’s stock has lost 1.7% this year so far. Bayer’s earnings estimates for 2022 have risen from $2.02 to $2.03 per share in the past 30 days.
Bayer beat earnings estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 18.23%. In the last reported quarter, Bayer’s earnings missed estimates by 3.33%.
Vertex’s stock has risen 38.1% this year so far. While Vertex’s earnings estimates for 2022 have risen from $14.21 to $14.61 per share in the past 30 days, estimates for 2023 have increased from $15.10 to $15.60 per share during the same period.
Vertex beat earnings estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 3.16%. In the last reported quarter, Vertex reported an earnings surprise of 8.67%.
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AstraZeneca's (AZN) Imfinzi/Imjudo Combo Gets Another FDA Nod
AstraZeneca (AZN - Free Report) announced that the FDA approveda dual immunotherapy regimen consisting of PD-L1 inhibitor Imfinzi (durvalumab) and CTLA-4 antibody Imjudo (tremelimumab). The candidate is combined with platinum-based chemotherapy for treating adult patients with Stage IV (metastatic) non-small cell lung cancer (“NSCLC”).
Per management, lung cancer is the second most common form of cancer across the world. Out of this, 80-85% of patients are classified as NSCLC. Once the NSCLC metastasizes, patient’s treatment does not respond well to standard therapies. AstraZeneca believes that a checkpoint inhibitor like Imfinzi combined with a limited course of CTLA-4 inhibition by Imjudo benefits patients in the long term.
This FDA approval of the Imfinzi+Imjudo combo is based on data from the phase III POSEIDON study, which evaluated the above combination as a first-line treatment of patients with metastatic NSCLC, irrespective of non-squamous or squamous disease. Data from the study showed that participants who received this combination exhibited a 23% reduction in the risk of death compared with those who received a wide range of chemotherapy options. Data from a four-year follow-up of patients also showed that the combination improved overall survival (OS) by 25% compared with chemotherapy alone.
Shares of AstraZeneca have gained 7.8% this year compared with the industry’s 2.9% rise.
Image Source: Zacks Investment Research
Imfinzi is already approved for multiple cancer indications. It is already approved for Stage III NSCLC patients following chemotherapy. It is approved for extensive-stage small cell lung cancer (ES-SCLC) and biliary tract cancer (BTC) indications. Last month, the combination of Imfinzi and Imjudo was approved by the FDA for treating unresectable hepatocellular carcinoma (uHCC) in adult patients.
AstraZeneca also filed regulatory applications seeking approval for the combination of Imfinzi, Imjudo and chemotherapy in NSCLC in Europe, Japan and several other countries currently under review.
AstraZeneca’s Imfinzi competes for market share with Keytruda, also a PD-1/PD-L1 inhibitor, developed by Merck (MRK - Free Report) . Merck’s Keytruda has been approved for the treatment of multiple cancer indications worldwide, including NSCLC. In the United States alone, Merck received approval for Keytruda in four NSCLC indications.
In the first nine months of 2022, Merck recorded $15.5 billion in sales from Keytruda. Sales of Keytruda continue to grow, driven by continued uptake in lung cancer and increasing usage in other cancer indications.
In a separate press release, AstraZeneca also announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the combination of Imfinzi plus chemotherapy as a treatment of unresectable or metastatic BTC in adult patients. The CHMP opinion is based on positive data from the phase III TOPAZ-1 study, which showed that the Imfinzi-chemotherapy combination reduced the risk of death by 24% compared with chemotherapy alone. This combination was approved by the FDA for a similar indication this September.
AstraZeneca PLC Price
AstraZeneca PLC price | AstraZeneca PLC Quote
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Bayer (BAYRY - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) , 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.
Bayer’s stock has lost 1.7% this year so far. Bayer’s earnings estimates for 2022 have risen from $2.02 to $2.03 per share in the past 30 days.
Bayer beat earnings estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 18.23%. In the last reported quarter, Bayer’s earnings missed estimates by 3.33%.
Vertex’s stock has risen 38.1% this year so far. While Vertex’s earnings estimates for 2022 have risen from $14.21 to $14.61 per share in the past 30 days, estimates for 2023 have increased from $15.10 to $15.60 per share during the same period.
Vertex beat earnings estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 3.16%. In the last reported quarter, Vertex reported an earnings surprise of 8.67%.