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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.

NICE shoots down Keytruda in head and neck cancer over data concerns

It has been revealed that NICE has chosen to reject MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) for routine use on the NHS as a treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC), citing uncertainty over the data provided by the manufacturer.

Data submitted to the institute argued that Keytruda, either as a monotherapy or in combination with platinum chemotherapy and 5-FU, extended overall survival in those with PD-L1 positive HNSCC compared to Eli Lilly’s Erbitux (cetuximab) plus platinum chemotherapy and 5-FU.

MSD's Keytruda chalks up bladder cancer approval in the US

MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) has added another US approval to its repertoire with the news that FDA has awarded marketing authorisation to the therapy for the treatment of a specific form of bladder cancer.

Specifically, the ruling was made in regard to patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

Bittersweet Phase 3 Keytruda data hits one of two goals in extensive stage small cell lung cancer

MSD has lifted the curtain on new Phase 3 data on the efficacy of its blockbuster immunotherapy Keytruda, in combination with etoposide plus cisplatin or carboplatin chemotherapy, in the treatment of extensive stage small cell lung cancer (ES-SCLC) in the first-line setting, showing that the combo met one of its primary endpoints, but not both.

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