Immuno-Oncology

FDA has granted a Priority Review designation for the breakthrough programmed death ligand-1 inhibitor atezolizumab, for the treatment of bladder cancer.

Supporting, funding, and protecting the research and development of new medicines and new treatments is more critical, now than ever, to provide better treatments and better outcomes to all cancer patients.

At the first annual conference of the Institute for Clinical Immuno-Oncology on October 1, 2015, in Philadelphia, the discussion revolved around integrating immuno-oncology into clinical practice and programs that assist with patient access to these treatments.

The new test, developed by Dako, will provide information on the survival benefit of patients with non-squamous NSCLC treated with nivolumab.

Metastatic melanoma patients treated with pembrolizumab responded better if their T cells had a higher level of Bim expression.

The submission by BMS includes results from the ELOQUENT-2 trial that were recently published in the New England Journal of Medicine.

With unprecedented activity in the area of precision medicine, with the successful development of several targeted therapies, the FDA has been in the forefront of efforts to ensure timely access to, and the safe and effective use of, these therapies.

Merck (MSD) has announced that its PD-1 inhibitor pembrolizumab (Keytruda) was approved by the European Commission for the treatment of advanced (unresectable or metastatic) melanoma in adults.

Nivolumab proved superior to everolimus in improving overall survival in previously treated patients.

Immuno-oncology continues to deliver results in oncology, as seen from results presented at the annual meeting of the American Society of Clinical Oncology. The combination of nivolumab and ipilimumab significantly improved survival in melanoma, while elotozumab showed encouraging results in relapsed refractory multiple myeloma.

A late-breaking abstract session early at the annual meeting of the American Society of Clinical Oncology presented datd for nivolumab in the treatment of hepatocellular carcinoma, non-squamous cell non-small cell lung cancer, and for tumors harboring mismatch repair deficiency.

The American Journal of Managed Care invited healthcare experts to discuss the challenges associated with managing and paying for newer and more expensive agents in oncology, during the Oncology Stakeholders Summit.

Two posters summarized the safety of nivolumab in lung cancer and in glioblastoma, at the ASCO annual meeting.

Scientists at Institut Pasteur in France have repurposed DPP4 inhibitors, used to treat type 2 diabetes mellitus, to boost the body's immune response to tumors.

BMS has submitted phase 3 results from the CheckMate-066 trial, comparing nivolumab with dacarbazine in treatment-naïve advanced melanoma patients.

Much-anticipated trial results were presented on the third day of the annual meeting of the American Society of Clinical Oncology, held in Chicago. These included phase 3 results from the CheckMate 067 trial and a phase 2 study with elotuzumab.

On the first day at the annual meeting of the American Society of Clinical Oncology in Chicago, physicians introduced some of the newer agents currently available to treat lymphoma and described their experience with these agents during the session, "Incorporating Novel Agents into Lymphoma Therapy: Value in Everyday Practice."

Amgen might be the latest entrant in the immunotherapy realm if the FDA heeds the advice of an independent advisory panel, recommending Amgen's anticancer viral therapy, T-Vec, for melanoma treatment.

A press release by Bristol-Myers Squibb announced their filing of a supplemental Biologics License Application for Opdivo (nivolumab) in the treatment of previously untreated individuals with advanced melanoma.

While lawmakers, payers, and patient advocates are raising a voice against the sky-rocketing costs of the newer breakthorugh agents in cancer, the drug developers can boast a strong start to the year with big sales figures.

The accelerated review, the results of which were made public 2 days prior to a vote by an FDA advisory panel on using T-Vec in melaonma, cited concerns over the design and results of a key study with the viral drug.

The monoclonal antibody MPDL3280A, a PD-L1 inhibitor being developed by Genentech, generated pharmacodynamic responses as measured by circulating biomarkers in phase 1a studies in patients with triple negative breast cancer.

With an aim to grab band-width in the shared PD-1 space, Merck has partnered with Syntax to conduct combination studies of Keytruda with Entinostat in melanoma and lung cancer patients.

The authors however cautioned that we still lack an understanding of biomarker-driven patient selection for PD-1 and PD-L1 agent. Adequate knowledge of the mechanism of action of these immuno-oncology agents could help optimize therapy, they add.

Currently, Keytruda is approved for patients with advanced melanoma previously treated with Yervoy and, in some patients, another type of drug as well. That second- and third-line status limits the number of patients eligible for the drug.

Dendreon's prostate cancer immunotherapy Provenge is now being backed by IQWiG just months after the German health technology assessor was poised to reject the treatment.

Merck and Eli Lilly have entered an agreement to collaborate on clinical trials to evaluate the former's recently approved PD-1 inhibitor, Keytruda (pembrolizumab) in combination with Lilly's oncology agents in several clinical trials targeting multiple tumor types.