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NICE recommends MSD's Keytruda for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma

NICE has moved to recommend the use of MSD’s blockbuster immunotherapy drug Keytruda (pembrolizumab) as a monotherapy in the treatment of previously untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

NICE estimates that around 950 patients in England and Wales with PD-L1-mutated tumours will be eligible to receive the therapy via the NHS based on this new decision.

Positive five-year Keytruda survival data revealed at ESMO in metastatic, PD-L1+ non-small cell lung cancer

MSD took the opportunity at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 to unveil new Phase 3 efficacy data for its anti-PD-1 therapy Keytruda (pembrolizumab) in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients with PD-L1-positive tumours with no EGFR or ALK genomic aberrations.

New Lenvima/Keytruda combo data in a range of cancers presented at ESMO 2020

New data from two studies investigating the combination of Eisai’s multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib) and MSD’s blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) were revealed at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

In the first study, the combo was found to generate an objective response rate (ORR) of 21.4% in the treatment of unresectable or advanced melanoma which has progressed following anti-PD-1/PD-L1 therapy, representing 22 out of 103 patients.

MSD and Eisai announce meaningful objective response rates for Keytruda+Lenvima combo in two cancer patient populations

MSD has pulled back the curtain on new data from two trials of its anti-PD-1 immunotherapy Keytruda (pemvbrolizmuab) in combination with Eisai’s Lenvima, showing that the combo demonstrated “clinically meaningful” rates of objective response in two separate patient populations.

In the first Phase 1b study of 100 unresectable hepatocellular carcinoma patients with no prior systemic therapy, the combo demonstrated an objective response rates (ORR) of 36%, with 1% achieving complete response and 35% achieving partial response.

MSD's Keytruda hits Phase 3 main goal in first-line colorectal cancer sub-population

MSD has lifted the veil on new Phase 3 for its blockbuster immunotherapy Keytruda, showing that the anti-PD-1 therapy met one of its main goals in the first-line treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer.

Data gathered during an interim analysis conducted by an independent Data Monitoring Committee (DMC) showed that the drug generated a “statistically significant and clinically meaningful improvement” in progression-free survival compared to an investigator’s choice of chemotherapy, meeting

Keytruda rejected for NHS use for bladder cancer, will be removed from the Cancer Drugs Fund

MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) has been knocked back by NICE for use on the NHS as a treatment for locally advanced or metastatic urothelial carcinoma in patients who have previously undergone platinum-containing chemotherapy.

Data harvested during the drug’s availability via the Cancer Drugs Fund and submitted in support of the application could not adequately address the institute’s concerns over its long-term benefit.  

New Keytruda dosing schedule rejected in six cancers by the FDA

MSD’s blockbuster immunotherapy Keytruda has been stopped in its tracks by the FDA after the US regulator rejected its application for a new dosing regimen in six different cancers: melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma, and Merkel cell carcinoma.

The therapy is already approved in those cancers when taken at 200mg dose every three weeks; the manufacturer was seeking to add the new dosing schedule of 400mg every six weeks on the grounds that it would provide patients with greater flexibility and mak

NICE gives initial ‘no’ to NHS England for kidney cancer drug

The National Institute for Health and Care Excellence (NICE) has not recommended Keytruda (pembrolizumab) and Inlyta (axitinib) for the treatment of advanced renal cell cancer.

Keytruda is an immunotherapy treatment that works by blocking a protein called PD-1 on the surface of certain immune cells called T cells, triggering the body’s immune system to kill cancer cells. It would be used in combination with Inlyta, which is already used to treat people with advanced kidney cancer whose cancer has continued to progress after initial treatment.

NICE does not recommend cancer drug combination to the NHS

NICE has published draft guidance that does not recommend a new drug combination to combat untreated advanced renal cell carcinoma in adults (RCC).

The evidence from treating kidney cancer patients with pembrolizumab (Keytruda) and axitinib (Inlyta) showed promise, but NICE were concerned about its long-term benefit. Its clinical and cost-effectiveness estimates were also above what NICE would normally consider as an acceptable use of NHS resources. 

Seattle Genetics and Astellas unveil positive results for Padcev-Keytruda treatment for bladder cancer

Seattle Genetics and Astellas reported positive results from their trials of Padcev plus Keytruda in treating bladder cancer.

The data from the Phase 2 trial shows that the treatment is meeting “outcome measures for safety and demonstrating encouraging clinical activity.” It was tested on two groups comprising 45 patients.

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