PERTH, Australia – Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab).
PERTH, Australia – Sydney-based Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer (NSCLC) and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s anti-PD-1 therapy, Keytruda (pembrolizumab).
The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy. Specifically, the assay will be used during the trial to analyze genomic markers to direct patient enrollment and stratification.
The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy.
PERTH, Australia – Australia is at risk of falling behind the U.S. and Europe in preventing recurrence of melanoma, the Melanoma Institute Australia warns. It is urging the Australian government to undertake a timely review of immunotherapy treatments effective in preventing the spread of melanoma and to fast track listings on the government-subsidized Pharmaceutical Benefits Scheme (PBS).
Shares of Seattle Genetics Inc. (NASDAQ:SGEN) rose 12.4% to $85.40 on news that an antibody-drug conjugate (ADC) it is developing with Tokyo-based Astellas Pharma Inc., when combined with Keytruda (pembrolizumab, Merck & Co. Inc.), shrank tumors in the majority of people participating in a phase I first-line bladder cancer study.
There have been three oncology drug approvals by the U.S. FDA over the last few years that were based solely on a genetic biomarker, rather than the location in the body where the tumor originated. But to make this tissue-agnostic approach a reality for oncology patients, detecting those genetic biomarkers will have to become increasingly easy and standardized.
BEIJING – Despite tensions between the U.S. and China, especially in the tech sector, Oncologie Inc. maintains its plans to pursue drug development in both markets. The clinical-stage startup, led by U.S. scientists and funded with Chinese capital, has stationed itself in both Boston and Shanghai to focus on developing innovative cancer therapies simultaneously in China and the U.S.