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MRK's Keytruda Combo Fails in Phase III Colorectal Cancer Study
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Merck (MRK - Free Report) announced data from the phase III KEYFORM-007 study, which evaluated a fixed-dose combination of its anti-LAG-3 antibody, favezelimab and its blockbuster anti-PD-1 therapy, Keytruda in pre-treated patients with PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC).
The study failed to meet the primary endpoint of overall survival (OS).
Year to date, shares of Merck have gained 5.2% compared with the industry’s rise of 22.8%.
Image Source: Zacks Investment Research
What Did MRK's KEYFORM-007 Study Show?
The randomized phase III KEYFORM-007 study evaluated the fixed-dose combination of favezelimab and Keytruda compared to standard of care, regorafenib for the treatment of patients with PD-L1 positive MSS mCRC who were previously treated with standard therapies.
At the final pre-specified analysis, treatment with favezelimab + Keytruda failed to demonstrate an improvement in OS versus standard of care – regorafenib in the given patient population.
The safety profile of favezelimab + Keytruda was similar to that of previously reported studies.
Full evaluation of the data from the KEYFORM-007 study is currently ongoing and the company plans to share the same with the scientific community later.
Keytruda is currently approved for treating patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer in the United States as determined by an FDA-approved test. However, the drug is not currently approved for the treatment of MSS mCRC.
The fixed-dose combination of favezelimab plus Keytruda is also being evaluated for certain hematologic malignancies and other solid tumor types. The phase III KEYFORM-008 study is evaluating the fixed-dose combination of favezelimab + Keytruda for treating patients with relapsed or refractory classical Hodgkin lymphoma whose disease has progressed following prior anti-PD-1 therapy.
Keytruda Gets Japan Nod for Certain Lung & Urothelial Cancers
In a separate press release, Merck announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Keytruda for three new indications in lung and urothelial cancers.
The MHLW approved Keytruda in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy as an adjuvant treatment in non-small cell lung carcinoma (NSCLC).
The Japanese regulatory body also approved Keytruda as a monotherapy for treating radically unresectable urothelial carcinoma in patients who are not eligible for any platinum-containing chemotherapy.
The MHLW also approved Keytruda in combination with Pfizer’s (PFE - Free Report) antibody-drug conjugate Padcev (enfortumab vedotin-ejfv) as a first-line treatment of patients with radically unresectable urothelial carcinoma.
The acquisition of Seagen in December 2023 added four antibody-drug conjugates or ADCs — Adcetris, Padcev, Tukysa and Tivdak to PFE’s portfolio of cancer drugs.
Pfizer is particularly witnessing strong demand for Padcev.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 3.9%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 48.6%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
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MRK's Keytruda Combo Fails in Phase III Colorectal Cancer Study
Merck (MRK - Free Report) announced data from the phase III KEYFORM-007 study, which evaluated a fixed-dose combination of its anti-LAG-3 antibody, favezelimab and its blockbuster anti-PD-1 therapy, Keytruda in pre-treated patients with PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC).
The study failed to meet the primary endpoint of overall survival (OS).
Year to date, shares of Merck have gained 5.2% compared with the industry’s rise of 22.8%.
Image Source: Zacks Investment Research
What Did MRK's KEYFORM-007 Study Show?
The randomized phase III KEYFORM-007 study evaluated the fixed-dose combination of favezelimab and Keytruda compared to standard of care, regorafenib for the treatment of patients with PD-L1 positive MSS mCRC who were previously treated with standard therapies.
At the final pre-specified analysis, treatment with favezelimab + Keytruda failed to demonstrate an improvement in OS versus standard of care – regorafenib in the given patient population.
The safety profile of favezelimab + Keytruda was similar to that of previously reported studies.
Full evaluation of the data from the KEYFORM-007 study is currently ongoing and the company plans to share the same with the scientific community later.
Keytruda is currently approved for treating patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer in the United States as determined by an FDA-approved test. However, the drug is not currently approved for the treatment of MSS mCRC.
The fixed-dose combination of favezelimab plus Keytruda is also being evaluated for certain hematologic malignancies and other solid tumor types. The phase III KEYFORM-008 study is evaluating the fixed-dose combination of favezelimab + Keytruda for treating patients with relapsed or refractory classical Hodgkin lymphoma whose disease has progressed following prior anti-PD-1 therapy.
Keytruda Gets Japan Nod for Certain Lung & Urothelial Cancers
In a separate press release, Merck announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Keytruda for three new indications in lung and urothelial cancers.
The MHLW approved Keytruda in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy as an adjuvant treatment in non-small cell lung carcinoma (NSCLC).
The Japanese regulatory body also approved Keytruda as a monotherapy for treating radically unresectable urothelial carcinoma in patients who are not eligible for any platinum-containing chemotherapy.
The MHLW also approved Keytruda in combination with Pfizer’s (PFE - Free Report) antibody-drug conjugate Padcev (enfortumab vedotin-ejfv) as a first-line treatment of patients with radically unresectable urothelial carcinoma.
The acquisition of Seagen in December 2023 added four antibody-drug conjugates or ADCs — Adcetris, Padcev, Tukysa and Tivdak to PFE’s portfolio of cancer drugs.
Pfizer is particularly witnessing strong demand for Padcev.
Merck's Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Fulcrum Therapeutics, Inc. (FULC - 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 ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 3.9%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 48.6%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.