MSD

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 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 has signed two new oncology-based deals with Seattle Genetics which together could be worth up to around $4.4 billion.

The first of the two deals will focus on the development of Seattle Genetics’ LIV-1 inhibitor iadiratuzumab vedotin alone and in combination with MSD’s blockbuster immunotherapy drug Keytruda (pembrolizumab) as a treatment for triple-negative breast cancer, hormone receptor-positive breast cancer and other solid tumours which express LIV-1.

MSD has lifted the lid on plans to build a $1.3 billion research centre in central London.

The London Discovery Research Centre, as the site is to be named, has a tentative opening date of 2025 and will be based opposite King’s Cross station.

Construction is due to commence in late 2021, contingent on a successful sign-off from the London borough of Camden. In order to free up the proposed 25,000-square-metre space, the existing group of buildings at the site will first need to be demolished.

Photo by FDA

The FDA has granted a fast Priority Review for Bayer and MSD’s heart failure drug vericiguat.

This was based on data from the Phase 3 VICTORIA study, which met its composite primary endpoint as the drug reduced the risk of heart failure hospitalisation or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction when compared with a placebo control group.

The European Commission has awarded approval to AstraZeneca and MSD’s Lynparza (olaparib) for germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer, with the drug becoming the only PARP inhibitor approved in Europe to treat the disease.

The ruling, which follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), specifically relates to gBRCAm patients with metastatic adenocarcinoma of the pancreas who have not seen disease progression following a minimum of 16 weeks of platinum treatment within a first line ch

Lynparza (olaparib), the PARP inhibitor developed by AstraZeneca and MSD, has just secured recommendation for approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) as a first-line maintenance treatment for germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.

The advice relates specifically to patients who have not seen their disease progress after receiving a minimum of 16 weeks of first-line platinum chemotherapy.

Lynparza (olaparib), developed by AstraZeneca and MSD, has secured FDA approval when paired with bevacizumab as a first-line maintenance treatment for homologous recombination deficiency (HRD)-positive advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.

The indication covers adult patients who have completely or partially responded to first-line platinum-based chemotherapy and whose HRD-positive status is defined by either a deleterious or suspected deleterious BRCA mutation or genomic instability.

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

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.