By Tristan Manalac The FDA has approved GSK’s Jemperli (dostarlimab-gxly) for the treatment of primary advanced or recurrent endometrial cancer, the company announced Monday. The label expansion covers a combination regimen of Jemperli, carboplatin and paclitaxel, followed by Jemperli as a single agent. Monday’s approval also only applies to patients who are mismatch repair deficient (dMMR), as confirmed by an FDA-approved test, or who have high microsatellite instability (MSI-H). Jemperli is the first immuno-oncology treatment and PD-1 inhibitor to be authorized for frontline use in this patient population, according to GSK. The expanded approval “redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer,” for whom chemotherapy alone has been the standard of care, though many patients still see disease progression, Hesham Abdullah, GSK’s senior vice president and global head of oncology development, said in a statement. Jemperli is an anti-PD-1 antibody that was first approved ...
GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation. The FDA has cleared Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer, GSK said Monday. To be eligible for the therapy, the patient’s tumor must be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), both terms that describe a type of genetic abormality. The approval comes nearly two months ahead of schedule and puts Jemperli ahead of Merck & Co.’s rival PD-1 inhibitor Keytruda, which is also gunning for the first-line endometrial cancer use. But the dMMR/MSI-H restriction comes as a bit of a disappointment for the GSK drug. By GSK’s estimate, about 15% to 20% of the roughly 60,000 new cases of endometrial cancer each year in the U.S. will be diagnosed at an advanced ...
By Tristan Manalac Pictured: Merck sign at its office in California/iStock, hapabapa Merck’s investigational pneumococcal vaccine V116 aced two Phase III trials, eliciting strong immune responses in both the Phase III STRIDE-3 and STRIDE-6 trials, the company announced Thursday. Without providing specific data, the drugmaker said that in STRIDE-3, V116 significantly outperformed the standard 20-valent pneumococcal conjugate vaccine at eliciting an immune response in adults who had not been immunized before. Meanwhile, STRIDE-6 showed that Merck’s investigational shot could prime immunity against all 21 targeted pneumococcal serotypes in adults aged 50 years and above who had been vaccinated at least a year prior. Both STRIDE-3 and STRIDE-6 also demonstrated that V116’s safety profile was comparable to the standard vaccine comparator used in these studies. “Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older,” Merck Chief Medical Officer Eliav Barr ...
Merck and Moderna announced Wednesday the initiation of a pivotal Phase III high-risk melanoma trial combining the companies’ mRNA-based personalized cancer vaccine with Merck’s blockbuster Keytruda checkpoint inhibitor. After a successful Phase IIb in stage III/IV melanoma patients with high risk of recurrence after surgery, Phase III is expanding the population to include stage IIb-IV patients. The study will enroll around 1,089 patients at more than 165 sites and in over 25 countries. The primary endpoint is recurrence-free survival. Secondary endpoints include distant metastasis-free survival and overall survival. Patients will receive either V940 (mRNA-4157), being co-developed and commercialized by Merck and Moderna, in combination with Keytruda or Keytruda alone for comparison. Phase IIb results shared earlier this year showed the cancer vaccine combined with Keytruda reduced risk of recurrence or death by 44% compared to Keytruda alone. Additional data in June 2023 showed the vaccine combo reduced risk of distant metastasis or death by 65% over ...
Merck & Co – known as MSD outside the US and Canada – has said its investigational GLP-1/glucagon receptor co-agonist, efinopegdutide (MK-6024), has demonstrated promising results in nonalcoholic fatty liver disease (NAFLD). NAFLD is a chronic and progressive condition in which fat builds up in the liver. It is known as a silent disease with few or no symptoms, however, certain health conditions such as obesity, metabolic syndrome and type 2 diabetes, increase the likelihood of developing NAFLD. There is not currently any approved medicine that can treat NAFLD, with treatment options focused on managing the problems associated with the condition. The findings, which will be presented at the European Association for the Study of the Liver (EASL) annual congress, include new data from a phase 2a randomised, open-label study evaluating the compound’s efficacy in liver fat reduction and safety against Novo Nordisk’s semaglutide in NAFLD patients. The candidate was ...
By Tristan Manalac Pictured: Syringe pulling vaccine from a vial / Adobe Stock, weyo Data from a Phase III study showed Valneva’s chikungunya vaccine candidate VLA1553 can elicit a strong immune response and could be an effective protective option against the mosquito-borne disease caused by the chikungunya virus, the French company announced Tuesday. This news follows a February 2023 report from Fierce Biotech revealing that Merck had dropped out of the chikungunya race. Citing a company spokesperson, Fierce noted that the decision to discontinue the chikungunya program was part of the company’s “routine pipeline prioritization.” Published Monday in the medical journal The Lancet, Valneva’s double-blinded and randomized Phase III study enrolled more than 4,100 participants who were given either VLA1553 or placebo. In the per-protocol analysis, the investigational shot induced neutralizing antibody titers above the protective threshold in 263 of 266 participants with evaluable findings. This corresponded to a 28-day ...
Merck & Co – known as MSD outside the US and Canada – has filed a lawsuit against the US government over the Medicare drug price negotiation element of President Biden’s Inflation Reduction Act (IRA). The IRA, which was enacted last year, allows Medicare – the government health plan for older adults – to negotiate lower prices for a selected group of prescription medicines. Merck argues that this violates the part of the Fifth Amendment to the US Constitution that requires the government to pay just compensation if it takes private property for public use. The lawsuit, filed in the US District Court for the District of Columbia, also argues that companies will be forced to sign agreements conceding that the prices are fair, which the drugmaker claims is a violation of the First Amendment’s protections of free speech. “These constitutional violations cannot be swept under the rug by pretending ...
The pharma industry has voiced loud complaints about the Biden administration’s Inflation Reduction Act, specifically focusing on a clause that will allow Medicare to negotiate the prices of top-selling pharmaceuticals. But now the industry is taking its arguments to the courts.In the first lawsuit of its kind, Merck & Co. is suing the Department of Health and Human Services for alleged violations of the First and Fifth Amendments to the U.S. Constitution, Reuters reports. Under the Inflation Reduction Act, Medicare will begin negotiating prices for the drugs that it spends the most on beginning in 2026. Because companies can’t exactly walk away from these negotiations, some industry leaders have said the setup is akin to “price controls.” Now, Merck alleges the negotiation setup is a violation of the Fifth Amendment, which requires the government to fairly compensate companies or individuals for property that is used for the public good, Reuters ...
Moderna and Merck’s experimental cancer vaccine, used in combination with Merck’s Keytruda, reduced the risk of the most deadly form of skin cancer spreading to other parts of the body in a clinical trial, according to the midstage trial results published Monday. Moderna and Merck’s cancer vaccine reduced the risk of melanoma spreading to other parts of the body or death by 65% in patients with stage 3 or 4 of the disease compared with patients who received Merck’s immunotherapy treatment alone, the trial has found. Moderna and Merck will present the data at the American Society of Clinical Oncology’s annual conference in Chicago at 5 p.m. ET. The clinical trial has enrolled 157 patients who have had their cancer surgically removed. Patients in the treatment group receive 1 milligram injections of the vaccine every three weeks for nine total doses and 200 mg intravenous infusions of Keytruda every three ...
After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has followed suit.Lynparza can now be used in combination with Johnson & Johnson’s Zytiga and a corticosteroid to treat patients with mCRPC whose tumors have BRCA mutations. The approval limits Lynparza’s use in the mCRPC population to about 10% of patients. The FDA’s decision comes after agency staffers and a committee of outside experts argued that the drug only showed a favorable risk-benefit in that population. Results from the phase 3 PROpel trial showed that the combo cut the risk of disease progression or death by 34% compared with solo Zytiga in newly diagnosed mCRPC patients regardless of mutation status. However, the FDA noted a “significant design flaw” with the trial in its briefing documents ahead of the meeting. Specifically, the FDA argued that the study didn’t ...
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