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MRK's Keytruda & Lynparza Combo Meets Goal in Ovarian Cancer Study
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Merck (MRK - Free Report) announced that its phase III KEYLYNK-001 study, evaluating its blockbuster anti-PD-1 therapy Keytruda regimen in advanced epithelial ovarian cancer met the primary endpoint of progression-free survival (PFS).
Keytruda is not approved to treat ovarian cancer at present.
The KEYLYNK-001 study evaluated Keytruda in combination with chemotherapy (paclitaxel and carboplatin) followed by Keytruda with maintenance Lynparza, with or without Avastin (bevacizumab), for the first-line treatment of BRCA non-mutated advanced epithelial ovarian cancer.
At final analysis, data from the study showed that the Keytruda plus Lynparza regimen led to a statistically significant and clinically meaningful improvement in PFS for these patients versus chemotherapy alone.
The final analysis was conducted by an independent Data Monitoring Committee. However, the study did not reach its secondary endpoint of overall survival. The safety profiles of Keytruda and Lynparza were similar to those observed in previously reported studies for the individual therapies.
Year to date, shares of Merck have declined 4.8% against the industry's increase of 9.4%.
Image Source: Zacks Investment Research
Recent Updates on MRK's Keytruda/Lynparza Combo
Per the company, the KEYLYNK-001 study is the first phase III study to demonstrate a positive outcome for the Keytruda plus Lynparza combo.
Recently, the Keytruda plus Lynparza combo faced some setbacks.
In March, MRK reported that a late-stage study evaluating the combination of Keytruda and Lynparza in metastatic non-squamous non-small cell lung cancer (NSCLC) failed to meet its primary endpoints.
The Keytruda and Lynparza combo also suffered a setback in metastatic squamous NSCLC indication, based on the data announced in December 2023. This study failed to show an improvement in overall survival, one of its dual primary endpoints.
In 2022, Merck stopped the phase III KEYLYNK-010 study evaluating the combination of Keytruda and Lynparza in patients with metastatic castration-resistant prostate cancer.
Lynparza, a PARP inhibitor, has been developed by Merck in collaboration with AstraZeneca (AZN - Free Report) . Lynparza is approved for four cancer types — ovarian, breast, prostate and pancreatic.
The profit-sharing deal between AZN and MRK was inked in 2017. Apart from Lynparza, the Merck-AstraZeneca deal also includes Koselugo.
Keytruda: A Key Revenue Driver for MRK
Keytruda is the biggest product in Merck’s portfolio. The drug has played an instrumental role in driving Merck’s steady revenue growth in the past few years. Keytruda sales continue to grow year over year as well as sequentially. The drug generated sales of more than $21 billion in the first nine months of 2024.
Keytruda sales benefited from rapid uptake across earlier-stage indications in triple-negative breast cancer, renal cell carcinoma and NSCLC. Continued strong momentum in metastatic indications also boosted sales growth.
This is one of the most successful cancer drugs ever and is considered a market leader for treating NSCLC. Keytruda is already approved for the treatment of many cancers globally and accounts for almost 50% of Merck’s pharmaceutical sales. However, Keytruda patents are set to lose exclusivity post 2028.
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 22.4%.
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 bottom line have moved from a loss of 58 cents per share to earnings of 34 cents per share. Loss per share estimates for 2025 have narrowed from $2.13 to $1.84 during the same time. Year to date, shares of CSTL have surged 43.2%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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MRK's Keytruda & Lynparza Combo Meets Goal in Ovarian Cancer Study
Merck (MRK - Free Report) announced that its phase III KEYLYNK-001 study, evaluating its blockbuster anti-PD-1 therapy Keytruda regimen in advanced epithelial ovarian cancer met the primary endpoint of progression-free survival (PFS).
Keytruda is not approved to treat ovarian cancer at present.
The KEYLYNK-001 study evaluated Keytruda in combination with chemotherapy (paclitaxel and carboplatin) followed by Keytruda with maintenance Lynparza, with or without Avastin (bevacizumab), for the first-line treatment of BRCA non-mutated advanced epithelial ovarian cancer.
At final analysis, data from the study showed that the Keytruda plus Lynparza regimen led to a statistically significant and clinically meaningful improvement in PFS for these patients versus chemotherapy alone.
The final analysis was conducted by an independent Data Monitoring Committee. However, the study did not reach its secondary endpoint of overall survival. The safety profiles of Keytruda and Lynparza were similar to those observed in previously reported studies for the individual therapies.
Year to date, shares of Merck have declined 4.8% against the industry's increase of 9.4%.
Image Source: Zacks Investment Research
Recent Updates on MRK's Keytruda/Lynparza Combo
Per the company, the KEYLYNK-001 study is the first phase III study to demonstrate a positive outcome for the Keytruda plus Lynparza combo.
Recently, the Keytruda plus Lynparza combo faced some setbacks.
In March, MRK reported that a late-stage study evaluating the combination of Keytruda and Lynparza in metastatic non-squamous non-small cell lung cancer (NSCLC) failed to meet its primary endpoints.
The Keytruda and Lynparza combo also suffered a setback in metastatic squamous NSCLC indication, based on the data announced in December 2023. This study failed to show an improvement in overall survival, one of its dual primary endpoints.
In 2022, Merck stopped the phase III KEYLYNK-010 study evaluating the combination of Keytruda and Lynparza in patients with metastatic castration-resistant prostate cancer.
Lynparza, a PARP inhibitor, has been developed by Merck in collaboration with AstraZeneca (AZN - Free Report) . Lynparza is approved for four cancer types — ovarian, breast, prostate and pancreatic.
The profit-sharing deal between AZN and MRK was inked in 2017. Apart from Lynparza, the Merck-AstraZeneca deal also includes Koselugo.
Keytruda: A Key Revenue Driver for MRK
Keytruda is the biggest product in Merck’s portfolio. The drug has played an instrumental role in driving Merck’s steady revenue growth in the past few years. Keytruda sales continue to grow year over year as well as sequentially. The drug generated sales of more than $21 billion in the first nine months of 2024.
Keytruda sales benefited from rapid uptake across earlier-stage indications in triple-negative breast cancer, renal cell carcinoma and NSCLC. Continued strong momentum in metastatic indications also boosted sales growth.
This is one of the most successful cancer drugs ever and is considered a market leader for treating NSCLC. Keytruda is already approved for the treatment of many cancers globally and accounts for almost 50% of Merck’s pharmaceutical sales. However, Keytruda patents are set to lose exclusivity post 2028.
MRK's Zacks Rank & Key Picks
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are Spero Therapeutics, Inc. (SPRO - Free Report) and Castle Biosciences, Inc. (CSTL - Free Report) , 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 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 22.4%.
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 bottom line have moved from a loss of 58 cents per share to earnings of 34 cents per share. Loss per share estimates for 2025 have narrowed from $2.13 to $1.84 during the same time. Year to date, shares of CSTL have surged 43.2%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.