JHOP Web Exclusives

Chicago, IL—Immunotherapy combinations are being studied intensively to determine which combinations hold the most promise in specific cancer types.

Chicago, IL—Tumors with high microsatellite instability (MSI-H) are predictive of Lynch syndrome. The recent approval of the first immunotherapies for use in patients with MSI-H or with mismatch repair-deficiency (dMMR) in solid tumors is now leading to routine testing for MSI-H or dMMR in patients with advanced solid tumors.

The novel drug sacituzumab govitecan is showing significant promise in HER2-negative breast cancers. “The benefit was durable, with an estimated medical duration of response of 7.4 months,” reported Aditya Bardia, MD, MPH.

“Both responders and those who didn’t respond to ivosidenib achieved transfusion independence. Ivosidenib was well-tolerated, and adverse events were managed with standard of care,” said Daniel A. Pollyea, MD, MS, at ASCO 2018.
FDA Commissioner Scott Gottlieb, MD, announced new steps as part of the FDA’s Drug Competition Action Plan to promote generic drug competition as a way to expand potential access to inexpensive medicines, which would be especially helpful for patients with cancer.
The NCCN’s first guideline for side effects from immunotherapy recognizes a new spectrum of events in patients who are receiving immune checkpoint inhibitor therapy.

Chimeric antigen receptor (CAR) T-cell therapy has had excellent results in late-stage leukemia and varying degrees of success in some other hematologic cancers, but thus far, solid tumors have not responded to this therapy.

In the FDA’s dynamic regulatory environment, the patient voice has been adopted and end points for clinical trials have evolved from overall survival to other efficacy measures. “Having multiple drugs is a good thing. Many are approved on nonsurvival end points, and they have transformed the diseases,” said Richard Pazdur, MD.

New results from the phase 3 QuANTUM-R trial showed that quizartinib, an oral, selective FLT3 inhibitor, significantly extended overall survival compared with chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) and the FLT3-ITD mutation.

This week Sellas Life Sciences Group announced data from a study of NeuVax (nelipepimut-S) in combination with Herceptin (trastuzumab) in patients with HER2 1+/2+ breast cancer.
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