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Merck (MRK), Seagen Drug Combo Gets FDA Nod for Bladder Cancer
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Merck (MRK - Free Report) along with partner Astellas Pharma and Seagen announced that the FDA has granted accelerated approval for the combination use of MRK’s blockbuster PD-L1 inhibitor, Keytruda plus Seagen’s antibody-drug conjugate, Padcev in a bladder cancer indication.
The approval is for Padcev in combination with Keytruda for the treatment of locally advanced or metastatic urothelial cancer, the most common type of bladder cancer, in patients who are not eligible to receive cisplatin-containing chemotherapy.
The accelerated approval was based on the tumor response rate and the durability of response data from some cohorts of the phase Ib/II KEYNOTE-869 study (also known as EV-103 study), which was conducted in collaboration with Seagen and Astellas. The data demonstrated a 68.0% confirmed objective response rate in patients treated with the Padcev + Keytruda combination. In the study, 12% of patients experienced a complete response and 55% of patients experienced a partial response.
However, the continued approval for this indication will be based on data from the ongoing phase III EV-302/KEYNOTE-A39 study, which will serve as the confirmatory study. The study is evaluating Keytruda in combination with Padcev in patients with previously untreated advanced urothelial cancer.
Merck’s stock has risen 30% in the past year compared with an increase of 4.2% for the industry.
Image Source: Zacks Investment Research
This is the first approval for a combination of an anti-PD-1 inhibitor and an antibody-drug conjugate in the United States in this patient group.
In bladder cancer, Keytruda is already approved as a monotherapy for treating locally advanced or metastatic urothelial carcinoma in patents who are not eligible for any platinum-containing chemotherapy, or whose disease has progressed during or following platinum-containing chemotherapy. It is also approved for treating Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors in patients who are ineligible for or have elected not to undergo cystectomy.
Some better-ranked drugmakers/biotech companies are Novo Nordisk (NVO - Free Report) and J&J (JNJ - Free Report) . While Novo Nordisk has a Zacks Rank of 1 (Strong Buy), J&J has a Zacks Rank #2 (Buy).
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.18 to $4.48. Estimates for 2024 have jumped from $4.70 per share to $5.28 in the past 60 days. Novo Nordisk’s stock has surged 39% in the past year.
Novo Nordisk beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 3.00%, on average.
Estimates for J&J’s 2023 earnings per share have increased from $10.49 to $10.50 while that for 2024 have jumped from $10.91 per share to $10.94 in the past 60 days. J&J’s stock has declined 11.7% in the past year.
J&J beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 2.94%, on average.
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Merck (MRK), Seagen Drug Combo Gets FDA Nod for Bladder Cancer
Merck (MRK - Free Report) along with partner Astellas Pharma and Seagen announced that the FDA has granted accelerated approval for the combination use of MRK’s blockbuster PD-L1 inhibitor, Keytruda plus Seagen’s antibody-drug conjugate, Padcev in a bladder cancer indication.
The approval is for Padcev in combination with Keytruda for the treatment of locally advanced or metastatic urothelial cancer, the most common type of bladder cancer, in patients who are not eligible to receive cisplatin-containing chemotherapy.
The accelerated approval was based on the tumor response rate and the durability of response data from some cohorts of the phase Ib/II KEYNOTE-869 study (also known as EV-103 study), which was conducted in collaboration with Seagen and Astellas. The data demonstrated a 68.0% confirmed objective response rate in patients treated with the Padcev + Keytruda combination. In the study, 12% of patients experienced a complete response and 55% of patients experienced a partial response.
However, the continued approval for this indication will be based on data from the ongoing phase III EV-302/KEYNOTE-A39 study, which will serve as the confirmatory study. The study is evaluating Keytruda in combination with Padcev in patients with previously untreated advanced urothelial cancer.
Merck’s stock has risen 30% in the past year compared with an increase of 4.2% for the industry.
Image Source: Zacks Investment Research
This is the first approval for a combination of an anti-PD-1 inhibitor and an antibody-drug conjugate in the United States in this patient group.
In bladder cancer, Keytruda is already approved as a monotherapy for treating locally advanced or metastatic urothelial carcinoma in patents who are not eligible for any platinum-containing chemotherapy, or whose disease has progressed during or following platinum-containing chemotherapy. It is also approved for treating Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors in patients who are ineligible for or have elected not to undergo cystectomy.
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked drugmakers/biotech companies are Novo Nordisk (NVO - Free Report) and J&J (JNJ - Free Report) . While Novo Nordisk has a Zacks Rank of 1 (Strong Buy), J&J has a Zacks Rank #2 (Buy).
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.18 to $4.48. Estimates for 2024 have jumped from $4.70 per share to $5.28 in the past 60 days. Novo Nordisk’s stock has surged 39% in the past year.
Novo Nordisk beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 3.00%, on average.
Estimates for J&J’s 2023 earnings per share have increased from $10.49 to $10.50 while that for 2024 have jumped from $10.91 per share to $10.94 in the past 60 days. J&J’s stock has declined 11.7% in the past year.
J&J beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 2.94%, on average.