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Merck's (MRK) Keytruda Gets Approval for Certain RCC Patients
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Merck (MRK - Free Report) announced that the FDA has approved its immuno-oncology drug Keytruda for yet another indication.
Keytruda, an anti-PD-1 therapy, is now approved for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence, following nephrectomy, or following nephrectomy and resection of metastatic lesions.
RCC is the most common type of kidney cancer. The approval was based on positive data from the phase III KEYNOTE-564 study, a multicenter, randomized, double-blind, placebo-controlled phase III study evaluating Keytruda as adjuvant therapy for RCC in 994 patients with intermediate-high or high risk of recurrence of RCC or M1 no evidence of disease (NED). Patients were randomized in the ratio of 1:1 to receive Keytruda 200 mg administered intravenously every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity.
Keytruda demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% compared to placebo.
Keytruda, approved for various oncology indications, is the key growth driver for Merck and further label expansion of the drug will aid the top line.
Merck’s stock has increased 1.5% this year so far compared with an increase of 15.8% for the industry.
Image Source: Zacks Investment Research
The advanced RCC treatment landscape has evolved in recent times and the focus shifted to immunotherapy-VEGF TKI combinations in earlier-line treatment. Most of these combinations showed immense promise.
Please note that Keytruda, in combination with Pfizer’s (PFE - Free Report) Inlya (axitinib), is already indicated for the first-line treatment of adult patients with advanced RCC.
Pfizer’s Inlyta has shown strong performance, driven by continued adoption in the United States and Europe. Pfizer’s older drug Sutent is also approved for advanced RCC.
Competition is stiff in this space. Exelixis’ (EXEL - Free Report) lead drug Cabometyx is also approved for advanced RCC among other indications.
In January 2021, the FDA approved Cabometyx in combination with immuno-oncology drug Bristol-Myers’ (BMY - Free Report) Opdivo for the first-line treatment of patients with advanced RCC.
Exelixis’ sales have witnessed a steady increase driven by the strong uptake for the combination therapy of Cabometyx and Opdivo.
Moreover, Bristol-Myers’ Opdivo is approved for various oncology indications and poses stiff competition to Keytruda in many targeted indications.
Separately, Merck announced an update regarding the phase II IMAGINE-DR study (MK-8507-13), which is evaluating the investigational combination of MK-8507, a non-nucleoside reverse transcriptase inhibitor, and islatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor, as a once-weekly oral treatment for HIV-1 infection.
Some of the study participants showed decreases in total lymphocyte and CD4+ T-cell counts. A review by the external Data Monitoring Committee (eDMC) determined that this effect was related to treatment with the combination of ISL+MK-850 and the greatest decreases were seen in the arms of the study receiving the highest doses of MK-8507 (200 mg and 400 mg). Consequently, Merck stopped dosing at the recommendation of the eDMC and paused the development of MK-8507.
Image: Shutterstock
Merck's (MRK) Keytruda Gets Approval for Certain RCC Patients
Merck (MRK - Free Report) announced that the FDA has approved its immuno-oncology drug Keytruda for yet another indication.
Keytruda, an anti-PD-1 therapy, is now approved for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence, following nephrectomy, or following nephrectomy and resection of metastatic lesions.
RCC is the most common type of kidney cancer. The approval was based on positive data from the phase III KEYNOTE-564 study, a multicenter, randomized, double-blind, placebo-controlled phase III study evaluating Keytruda as adjuvant therapy for RCC in 994 patients with intermediate-high or high risk of recurrence of RCC or M1 no evidence of disease (NED). Patients were randomized in the ratio of 1:1 to receive Keytruda 200 mg administered intravenously every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity.
Keytruda demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% compared to placebo.
Keytruda, approved for various oncology indications, is the key growth driver for Merck and further label expansion of the drug will aid the top line.
Merck’s stock has increased 1.5% this year so far compared with an increase of 15.8% for the industry.
The advanced RCC treatment landscape has evolved in recent times and the focus shifted to immunotherapy-VEGF TKI combinations in earlier-line treatment. Most of these combinations showed immense promise.
Please note that Keytruda, in combination with Pfizer’s (PFE - Free Report) Inlya (axitinib), is already indicated for the first-line treatment of adult patients with advanced RCC.
Pfizer’s Inlyta has shown strong performance, driven by continued adoption in the United States and Europe. Pfizer’s older drug Sutent is also approved for advanced RCC.
Competition is stiff in this space. Exelixis’ (EXEL - Free Report) lead drug Cabometyx is also approved for advanced RCC among other indications.
In January 2021, the FDA approved Cabometyx in combination with immuno-oncology drug Bristol-Myers’ (BMY - Free Report) Opdivo for the first-line treatment of patients with advanced RCC.
Exelixis’ sales have witnessed a steady increase driven by the strong uptake for the combination therapy of Cabometyx and Opdivo.
Moreover, Bristol-Myers’ Opdivo is approved for various oncology indications and poses stiff competition to Keytruda in many targeted indications.
Separately, Merck announced an update regarding the phase II IMAGINE-DR study (MK-8507-13), which is evaluating the investigational combination of MK-8507, a non-nucleoside reverse transcriptase inhibitor, and islatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor, as a once-weekly oral treatment for HIV-1 infection.
Some of the study participants showed decreases in total lymphocyte and CD4+ T-cell counts. A review by the external Data Monitoring Committee (eDMC) determined that this effect was related to treatment with the combination of ISL+MK-850 and the greatest decreases were seen in the arms of the study receiving the highest doses of MK-8507 (200 mg and 400 mg). Consequently, Merck stopped dosing at the recommendation of the eDMC and paused the development of MK-8507.
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.