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Keytruda fails to improve overall survival in advanced triple-negative breast cancer

MSD has made it known that its cancer immunotherapy Keytruda (pembrolizumab) failed to meet its primary endpoint in a Phase 3 study evaluating its efficacy as a monotherapy for the second- or third-line treatment of metastatic triple-negative breast cancer (TNBC).

The company revealed that the blockbuster anti-PD-1 drug failed to show superiority in improving overall survival compared to chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine). Because this primary endpoint was never met, all other endpoints were not formally tested.

MSD's Keytruda recommended on NHS in Scotland for Stage 3 melanoma

MSD has revealed that Keytruda (pembrolizumab) will be made available to NHS Scotland patients after the Scottish Medicines Consortium (SMC) decided to recommend the drug’s use as a monotherapy in the treatment of Stage 3 melanoma with lymph node involvement in adult patients who have undergone complete resection.

Thanks to the decision, access to the drug in this indication is now harmonised across the Great British mainland, following a recommendation from NICE in December 2018 to make the immunotherapy available on the NHS in England and Wales.

Keytruda/Inlyta combo scores FDA approval in advanced kidney cancer

MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) has secured another approval from the FDA, this time as a first-line treatment in combination with Pfizer’s Inlyta (axitinib) in advanced renal cell carcinoma.

The FDA made the decision based on Phase 3 data which showed that the combo significantly improved overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to Pfizer’s Sutent (sunitinib).

FDA expands Keytruda label to include stage 3 and 4 non-small cell lung cancer

MSD has revealed that its anti-PD-1 therapy Keytruda (pembrolizumab) has received expanded indication from the FDA to include the first-line treatment of stage 3 or metastatic non-small cell lung cancer (NSCLC).

Specifically, the indication relates to stage 3 patients who are not candidates for surgical resection or definitive chemoradiation, and those whose tumours express PD-L1 as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.

China approves Keytruda for non-small cell lung cancer

US firm MSD has won approval for Keytruda in China. The cancer immunotherapy has thus become the first PD-1 inhibitor approved for multiple tumour types in China.

The approval makes Keytruda (pembrolizumab) a first line treatment option alongside chemotherapy for patients in China with metastatic non-squamous non-small cell lung cancer (NSCLC). The indication brought in more than $7 billion in sales in 2018.

MSD's Keytruda/chemo combo nabs EU approval in first-line metastatic squamous lung cancer

MSD’s anti-PD-L1 therapy Keytruda (pembrolizumab) has been awarded marketing authorisation in Europe for the first-line treatment of adult patients with metastatic squamous non-small cell lung cancer (NSCLC) when used in combination with carboplatin and either paclitaxel or nab-paclitaxel, it has emerged.

Phase 3 data submitted in support of the application illustrated that the combo “significantly improved overall survival (OS)”, reducing risk of death by 36% compared to chemotherapy alone regardless of a patient’s PD-L1 tumour expression status.

Top Ten most popular articles on Pharmafile.com this week

Happy Friday! With the weekend within reach, check out our run-down of the top ten most popular articles on Pharmafile.com this week, including Keytruda's liver cancer failure, a "game-changing osteoasrthritis treatment, AstraZeneca's retirement of the MedImmune brand, and the promise of the first new asthma pill in two decades.

10. Poland and Slovenia included in US-EU mutual recognition agreement

Keytruda falls short at Phase 3 in advanced liver cancer

MSD has revealed new Phase 3 data which indicates that its blockbuster immunotherapy Keytruda (pembrolizumab), in combination with best supportive care, failed to meet its primary endpoints of overall survival or progression-free survival in the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy.

The company noted that both rates for the Keytruda arm of the study were superior to those in the placebo arm, but these did not reach statistical significance.

MSD's Keytruda combo therapy significantly improves survival in advanced renal cell carcinoma

Merck & Co’s Keytruda (pembrolizumab) in combination with Pfizer’s Inlyta (axitinib) significantly extended the lives of those with advanced renal cell carcinoma (RCC) and delayed disease progression and death according to the results of a Phase 3 clinical trial.

The combo outperformed Pfizer’s Sutent – the current standard of care first line treatment for advanced RCC patients.

Keytruda + Inlyta combo beats Pfizer's chemotherapy Sutent in renal cell carcinoma

New data has been revealed on the efficacy of MSD’s Keytruda (pembrolizumab) in combination with Pfizer’s Inlyta (axitinib), showing it successfully reduced the risk of death by almost half in advanced renal carcinoma (RCC) patients compared to Pfizer’s chemotherapy drug Sutent.

Specifically, the combo reduced the risk of death in RCC by 47%, while risk of disease progression or death was reduced by almost 40%. In addition, overall response rate was 20% higher than that shown by Sutent.  

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