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Seagen's (SGEN) Padcev & Keytruda Combo Gets FDA Accelerated Nod
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Seagen Inc. and partner, Astellas Pharma, announced that the FDA has granted accelerated approval to the combination therapy of Padcev with Merck’s (MRK - Free Report) Keytruda for the treatment of adult patients with first and second-line metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. The continued approval for this indication is subject to the results of the companies’ confirmatory phase III EV-302 study.
In the past year, shares of Seagen have shot up 34% against the industry’s 15.6% decline.
Image Source: Zacks Investment Research
The FDA’s accelerated approval is based on objective response rates (ORR) and median duration of response (DOR), observed in both cohorts of the phase Ib/II EV-103 study, Cohort A with dose escalation and Cohort K. In both cohorts, patients treated with Padcev in combination with Keytruda witnessed a confirmed ORR of 68% among which 12% of patients experienced a complete response and 55% of patients experienced a partial response. The median DOR observed in Cohort A with dose escalation was 22.1 months while the same was not reached in Cohort K. The median number of treatment cycles was nine in Cohort A and 11 in Cohort K.
Some mild-to-moderate adverse events were also observed during the study.
We would like to remind investors that in September 2022, Seagen, Astellas and Merck announced encouraging data from the phase Ib/II EV-103 study of Cohort K, evaluating Padcev in combination with Keytruda, for first-line treatment of patients with unresectable locally advanced or metastatic urothelial cancer, who are ineligible to receive cisplatin-based chemotherapy. Based on this data, a supplemental biologics license application was filed with the FDA for Padcev, in combination with Keytruda, as a first-line treatment for advanced urothelial cancer in October.
Padcev, Seagen’s second drug, was initially approved by the FDA in December 2019 on an accelerated basis for the treatment of patients with advanced/metastatic urothelial cancer who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.
Merck’s blockbuster oncology drug, Keytruda, is approved for several types of cancer, accounting alone for around 40% of Merck’s pharmaceutical sales. Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally.
The phase III EV-302 confirmatory study evaluating the clinical benefit of Padcev in combination with Keytruda in patients with previously untreated advanced urothelial cancer is currently ongoing. Seagen, Astellas and Merck have announced the completion of global enrollment, barring the China extension, which is reportedly enrolling patients.
In the past 90 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 56 cents. In the past year, shares of Aptinyx have fallen by 95.2%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.
In the past 90 days, the consensus estimate for ADMA’s 2023 loss per share has narrowed from 19 cents to 14 cents. In the past year, shares of ADMA have increased by 58.8%.
ADMA beat estimates in three out of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 2.88%.
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Seagen's (SGEN) Padcev & Keytruda Combo Gets FDA Accelerated Nod
Seagen Inc. and partner, Astellas Pharma, announced that the FDA has granted accelerated approval to the combination therapy of Padcev with Merck’s (MRK - Free Report) Keytruda for the treatment of adult patients with first and second-line metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. The continued approval for this indication is subject to the results of the companies’ confirmatory phase III EV-302 study.
In the past year, shares of Seagen have shot up 34% against the industry’s 15.6% decline.
Image Source: Zacks Investment Research
The FDA’s accelerated approval is based on objective response rates (ORR) and median duration of response (DOR), observed in both cohorts of the phase Ib/II EV-103 study, Cohort A with dose escalation and Cohort K. In both cohorts, patients treated with Padcev in combination with Keytruda witnessed a confirmed ORR of 68% among which 12% of patients experienced a complete response and 55% of patients experienced a partial response. The median DOR observed in Cohort A with dose escalation was 22.1 months while the same was not reached in Cohort K. The median number of treatment cycles was nine in Cohort A and 11 in Cohort K.
Some mild-to-moderate adverse events were also observed during the study.
We would like to remind investors that in September 2022, Seagen, Astellas and Merck announced encouraging data from the phase Ib/II EV-103 study of Cohort K, evaluating Padcev in combination with Keytruda, for first-line treatment of patients with unresectable locally advanced or metastatic urothelial cancer, who are ineligible to receive cisplatin-based chemotherapy. Based on this data, a supplemental biologics license application was filed with the FDA for Padcev, in combination with Keytruda, as a first-line treatment for advanced urothelial cancer in October.
Padcev, Seagen’s second drug, was initially approved by the FDA in December 2019 on an accelerated basis for the treatment of patients with advanced/metastatic urothelial cancer who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.
Merck’s blockbuster oncology drug, Keytruda, is approved for several types of cancer, accounting alone for around 40% of Merck’s pharmaceutical sales. Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally.
The phase III EV-302 confirmatory study evaluating the clinical benefit of Padcev in combination with Keytruda in patients with previously untreated advanced urothelial cancer is currently ongoing. Seagen, Astellas and Merck have announced the completion of global enrollment, barring the China extension, which is reportedly enrolling patients.
Seagen Inc. Price and Consensus
Seagen Inc. price-consensus-chart | Seagen Inc. Quote
Zacks Rank and Stocks to Consider
Seagen currently has a Zacks Rank #3 (Hold).
A couple of top-ranked stocks in the same industry are Aptinyx and ADMA Biologics (ADMA - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 56 cents. In the past year, shares of Aptinyx have fallen by 95.2%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.
In the past 90 days, the consensus estimate for ADMA’s 2023 loss per share has narrowed from 19 cents to 14 cents. In the past year, shares of ADMA have increased by 58.8%.
ADMA beat estimates in three out of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 2.88%.