WELIREG and KEYTRUDA Combination Shows Positive Phase 3 Results in Kidney Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
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Should l Buy MRK?
Source: Newsfilter
- Clinical Trial Breakthrough: The combination of WELIREG and KEYTRUDA demonstrated a significant improvement in disease-free survival in the LITESPARK-022 trial, reducing the risk of disease recurrence or death by 28% (HR=0.72, p=0.0003), providing a new treatment option for kidney cancer patients.
- FDA Priority Review: Based on the trial results, the U.S. FDA has accepted supplemental applications for the combination therapy for priority review, with a target action date set for June 19, 2026, potentially accelerating the market introduction of this therapy.
- Significant Patient Benefit: In the trial, the 24-month disease-free survival rate for the KEYTRUDA plus WELIREG arm was 80.7%, significantly higher than the 73.7% for KEYTRUDA monotherapy, bringing new hope to treatment strategies for renal cell carcinoma.
- Good Safety Profile: The safety of the combination therapy was consistent with previous studies, with no new safety signals observed, and 69.5% of patients completed the treatment, indicating good tolerability and the potential to reshape clinical practice.
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Analyst Views on MRK
Wall Street analysts forecast MRK stock price to rise
16 Analyst Rating
11 Buy
5 Hold
0 Sell
Moderate Buy
Current: 119.300
Low
95.00
Averages
119.53
High
139.00
Current: 119.300
Low
95.00
Averages
119.53
High
139.00
About MRK
Merck & Co., Inc. is a global health care company that delivers health solutions through its prescription medicines, including biologic therapies, vaccines and animal health products. Its Pharmaceutical segment includes human health pharmaceutical and vaccine products. The Company sells its human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed health care providers. It sells these human health vaccines primarily to physicians, wholesalers, distributors and government entities. Its Animal Health segment discovers, develops, manufactures and markets a range of veterinary pharmaceutical and vaccine products, as well as health management solutions and services, for the prevention, treatment and control of disease in all livestock and companion animal species. Its products include KEYTRUDA (pembrolizumab) injection, for intravenous use; WELIREG (belzutifan) tablets, for oral use; Ohtuvayre (ensifentrine) and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
KEYTRUDA® (PEMBROLIZUMAB) COMBINED WITH PACLITAXEL, WITH OR WITHOUT BEVACIZUMAB, SHOWS SIGNIFICANT IMPROVEMENT IN OVERALL SURVIVAL IN PATIENTS WITH PLATINUM-RESISTANT RECURRENT OVARIAN CANCER COMPARED TO PACLITAXEL ALONE OR WITH BEVACIZUMAB.
Key Findings: The study indicates that Keytruda (pembrolizumab) significantly improves overall survival in patients with platinum-resistant recurrent ovarian cancer compared to paclitaxel, regardless of bevacizumab use.
Patient Population: The research focuses on patients suffering from platinum-resistant recurrent ovarian cancer, highlighting the effectiveness of Keytruda in this specific group.
Treatment Comparison: The results suggest a notable difference in survival rates between those treated with Keytruda and those receiving paclitaxel, emphasizing the potential benefits of immunotherapy.
Clinical Implications: These findings may influence treatment protocols for ovarian cancer, advocating for the inclusion of Keytruda as a viable option for improving patient outcomes.
See More
KEYTRUDA® (PEMBROLIZUMAB) AND PADCEV® (ENFORTUMAB VEDOTIN-EJFV) LOWERED THE RISK OF EVENT-FREE SURVIVAL BY 47% AND DEATH BY 35% IN CISPLATIN-ELIGIBLE PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER WHEN ADMINISTERED BEFORE AND AFTER SURGERY
Key Findings: The use of Keytruda (pembrolizumab) and Padcev (enfortumab vedotin) significantly reduces the risk of event-free survival events by 47% and the risk of death by 35% for cisplatin-eligible patients with muscle-invasive bladder cancer.
Patient Population: The study focuses on patients diagnosed with muscle-invasive bladder cancer who are eligible for cisplatin treatment.
Treatment Timing: The effectiveness of these treatments is noted both before and after surgical intervention.
Clinical Implications: These findings suggest a promising approach to improving survival rates in patients with this type of cancer.
See More
Merck Animal Health's Numelvi Approved by FDA for Allergic Dermatitis in Dogs
- New Drug Approval: Merck Animal Health's JAK inhibitor Numelvi (atinvicitinib) has received FDA approval for controlling pruritus related to allergic dermatitis in dogs, marking it as the first second-generation JAK inhibitor approved for this indication, which is expected to significantly enhance the quality of life for canine patients.
- Market Launch Timing: Numelvi is set to be available starting in the spring, and with the launch of this new drug, Merck Animal Health is poised to capture a larger share of the pet healthcare market, addressing the growing demand for pet care solutions.
- Investor Confidence: Despite facing patent risks, analysts remain bullish on Merck, believing that the introduction of this new drug will bolster the company's revenue streams and further solidify its leadership position in the animal health sector.
- Industry Impact: The approval of Numelvi not only provides pet owners with a new treatment option but may also drive innovation across the animal health industry, prompting other companies to accelerate their drug development processes.
See More
Merck and Eisai Present New Data on Kidney Cancer Therapy
- Clinical Trial Results: The Phase 3 LITESPARK-011 trial demonstrated that the combination of WELIREG and LENVIMA significantly improved progression-free survival (PFS), with a median PFS of 14.8 months compared to 10.7 months for cabozantinib, reducing the risk of disease progression or death by 30% (HR=0.70).
- FDA Application Progress: Based on the LITESPARK-011 trial data, the U.S. FDA has accepted two supplemental New Drug Applications (sNDA) for WELIREG and LENVIMA, with a target action date of October 4, 2026, marking a significant milestone for the company in the kidney cancer treatment space.
- Patient Response Rate: In the trial, 52.6% of patients responded to the combination treatment of WELIREG and LENVIMA, highlighting the potential of this regimen for patients with advanced renal cell carcinoma and further solidifying Merck's leadership in oncology.
- Safety Analysis: While 71.6% of patients experienced grade 3 or higher adverse events during treatment with WELIREG and LENVIMA, the safety profile remains acceptable compared to cabozantinib, indicating promising clinical applicability for this combination.
See More
Merck's KEYTRUDA and WELIREG Show Promising Results in Kidney Cancer Treatment
- Clinical Trial Results: At the 2026 American Society of Clinical Oncology (ASCO) meeting, Merck presented results from the LITESPARK-022 Phase 3 trial, demonstrating that the combination of KEYTRUDA and WELIREG significantly improved disease-free survival in renal cell carcinoma patients, reducing the risk of recurrence or death by 28% (HR=0.72, p=0.0003), offering new hope for kidney cancer treatment.
- Significant Patient Benefit: In the first pre-specified interim analysis with a median follow-up of 28.4 months, the 24-month disease-free survival rate was 80.7% for the KEYTRUDA plus WELIREG arm, notably higher than the 73.7% for KEYTRUDA monotherapy, providing a new treatment option for high-risk patients that could reshape clinical practice.
- FDA Priority Review: Following the positive results from LITESPARK-022, the FDA has accepted priority review applications for the combination of WELIREG with KEYTRUDA, with a target action date set for June 19, 2026, which could provide more effective treatment options for kidney cancer patients if approved.
- Good Safety Profile: The safety profile of the KEYTRUDA and WELIREG combination was consistent with previously reported studies, with no new safety signals observed, and 69.5% of patients completing the treatment, indicating good tolerability and enhancing its potential for clinical application.
See More
WELIREG and KEYTRUDA Combination Shows Positive Phase 3 Results in Kidney Cancer
- Clinical Trial Breakthrough: The combination of WELIREG and KEYTRUDA demonstrated a significant improvement in disease-free survival in the LITESPARK-022 trial, reducing the risk of disease recurrence or death by 28% (HR=0.72, p=0.0003), providing a new treatment option for kidney cancer patients.
- FDA Priority Review: Based on the trial results, the U.S. FDA has accepted supplemental applications for the combination therapy for priority review, with a target action date set for June 19, 2026, potentially accelerating the market introduction of this therapy.
- Significant Patient Benefit: In the trial, the 24-month disease-free survival rate for the KEYTRUDA plus WELIREG arm was 80.7%, significantly higher than the 73.7% for KEYTRUDA monotherapy, bringing new hope to treatment strategies for renal cell carcinoma.
- Good Safety Profile: The safety of the combination therapy was consistent with previous studies, with no new safety signals observed, and 69.5% of patients completed the treatment, indicating good tolerability and the potential to reshape clinical practice.
See More
KEYTRUDA® (PEMBROLIZUMAB) COMBINED WITH PACLITAXEL, WITH OR WITHOUT BEVACIZUMAB, SHOWS SIGNIFICANT IMPROVEMENT IN OVERALL SURVIVAL IN PATIENTS WITH PLATINUM-RESISTANT RECURRENT OVARIAN CANCER COMPARED TO PACLITAXEL ALONE OR WITH BEVACIZUMAB.
Key Findings: The study indicates that Keytruda (pembrolizumab) significantly improves overall survival in patients with platinum-resistant recurrent ovarian cancer compared to paclitaxel, regardless of bevacizumab use.
Patient Population: The research focuses on patients suffering from platinum-resistant recurrent ovarian cancer, highlighting the effectiveness of Keytruda in this specific group.
Treatment Comparison: The results suggest a notable difference in survival rates between those treated with Keytruda and those receiving paclitaxel, emphasizing the potential benefits of immunotherapy.
Clinical Implications: These findings may influence treatment protocols for ovarian cancer, advocating for the inclusion of Keytruda as a viable option for improving patient outcomes.
See More
KEYTRUDA® (PEMBROLIZUMAB) AND PADCEV® (ENFORTUMAB VEDOTIN-EJFV) LOWERED THE RISK OF EVENT-FREE SURVIVAL BY 47% AND DEATH BY 35% IN CISPLATIN-ELIGIBLE PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER WHEN ADMINISTERED BEFORE AND AFTER SURGERY
Key Findings: The use of Keytruda (pembrolizumab) and Padcev (enfortumab vedotin) significantly reduces the risk of event-free survival events by 47% and the risk of death by 35% for cisplatin-eligible patients with muscle-invasive bladder cancer.
Patient Population: The study focuses on patients diagnosed with muscle-invasive bladder cancer who are eligible for cisplatin treatment.
Treatment Timing: The effectiveness of these treatments is noted both before and after surgical intervention.
Clinical Implications: These findings suggest a promising approach to improving survival rates in patients with this type of cancer.
See More
Merck Animal Health's Numelvi Approved by FDA for Allergic Dermatitis in Dogs
- New Drug Approval: Merck Animal Health's JAK inhibitor Numelvi (atinvicitinib) has received FDA approval for controlling pruritus related to allergic dermatitis in dogs, marking it as the first second-generation JAK inhibitor approved for this indication, which is expected to significantly enhance the quality of life for canine patients.
- Market Launch Timing: Numelvi is set to be available starting in the spring, and with the launch of this new drug, Merck Animal Health is poised to capture a larger share of the pet healthcare market, addressing the growing demand for pet care solutions.
- Investor Confidence: Despite facing patent risks, analysts remain bullish on Merck, believing that the introduction of this new drug will bolster the company's revenue streams and further solidify its leadership position in the animal health sector.
- Industry Impact: The approval of Numelvi not only provides pet owners with a new treatment option but may also drive innovation across the animal health industry, prompting other companies to accelerate their drug development processes.
See More
Merck and Eisai Present New Data on Kidney Cancer Therapy
- Clinical Trial Results: The Phase 3 LITESPARK-011 trial demonstrated that the combination of WELIREG and LENVIMA significantly improved progression-free survival (PFS), with a median PFS of 14.8 months compared to 10.7 months for cabozantinib, reducing the risk of disease progression or death by 30% (HR=0.70).
- FDA Application Progress: Based on the LITESPARK-011 trial data, the U.S. FDA has accepted two supplemental New Drug Applications (sNDA) for WELIREG and LENVIMA, with a target action date of October 4, 2026, marking a significant milestone for the company in the kidney cancer treatment space.
- Patient Response Rate: In the trial, 52.6% of patients responded to the combination treatment of WELIREG and LENVIMA, highlighting the potential of this regimen for patients with advanced renal cell carcinoma and further solidifying Merck's leadership in oncology.
- Safety Analysis: While 71.6% of patients experienced grade 3 or higher adverse events during treatment with WELIREG and LENVIMA, the safety profile remains acceptable compared to cabozantinib, indicating promising clinical applicability for this combination.
See More
Merck's KEYTRUDA and WELIREG Show Promising Results in Kidney Cancer Treatment
- Clinical Trial Results: At the 2026 American Society of Clinical Oncology (ASCO) meeting, Merck presented results from the LITESPARK-022 Phase 3 trial, demonstrating that the combination of KEYTRUDA and WELIREG significantly improved disease-free survival in renal cell carcinoma patients, reducing the risk of recurrence or death by 28% (HR=0.72, p=0.0003), offering new hope for kidney cancer treatment.
- Significant Patient Benefit: In the first pre-specified interim analysis with a median follow-up of 28.4 months, the 24-month disease-free survival rate was 80.7% for the KEYTRUDA plus WELIREG arm, notably higher than the 73.7% for KEYTRUDA monotherapy, providing a new treatment option for high-risk patients that could reshape clinical practice.
- FDA Priority Review: Following the positive results from LITESPARK-022, the FDA has accepted priority review applications for the combination of WELIREG with KEYTRUDA, with a target action date set for June 19, 2026, which could provide more effective treatment options for kidney cancer patients if approved.
- Good Safety Profile: The safety profile of the KEYTRUDA and WELIREG combination was consistent with previously reported studies, with no new safety signals observed, and 69.5% of patients completing the treatment, indicating good tolerability and enhancing its potential for clinical application.
See More
WELIREG and KEYTRUDA Combination Shows Positive Phase 3 Results in Kidney Cancer
- Clinical Trial Breakthrough: The combination of WELIREG and KEYTRUDA demonstrated a significant improvement in disease-free survival in the LITESPARK-022 trial, reducing the risk of disease recurrence or death by 28% (HR=0.72, p=0.0003), providing a new treatment option for kidney cancer patients.
- FDA Priority Review: Based on the trial results, the U.S. FDA has accepted supplemental applications for the combination therapy for priority review, with a target action date set for June 19, 2026, potentially accelerating the market introduction of this therapy.
- Significant Patient Benefit: In the trial, the 24-month disease-free survival rate for the KEYTRUDA plus WELIREG arm was 80.7%, significantly higher than the 73.7% for KEYTRUDA monotherapy, bringing new hope to treatment strategies for renal cell carcinoma.
- Good Safety Profile: The safety of the combination therapy was consistent with previous studies, with no new safety signals observed, and 69.5% of patients completed the treatment, indicating good tolerability and the potential to reshape clinical practice.
See More
