As part of a U.S. FDA evaluation of confirmatory trials for anti-PD-1/PD-L1 antibodies, the agency’s Oncologic Drugs Advisory Committee (ODAC) is being asked this week to consider whether three blockbuster biologics should continue to be available for certain cancer indications for which they received accelerated approval. At question is whether the data from the confirmatory trials for the Roche Group’s Tecentriq (atezolizumab), Merck & Co. Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Co.’s Opdivo (nivolumab) has proved sufficient benefit in particular indications and, if not, whether alternative or ongoing trials could do so.
Oncology drugs that have racked up a number of indications through accelerated approvals are losing some of those indications as the result of an FDA industrywide evaluation of confirmatory trials that didn’t back up the approvals.
The 2020 World Conference on Lung Cancer, which was scheduled to take place in Singapore last August, is set to kick off virtually later this week. The postponement gave companies time to generate additional data as they battle to treat patients with their targeted therapies.
HONG KONG – Tokyo-based Chugai Pharmaceutical Co. Ltd., a subsidiary of Roche Holding AG, has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) to add new indication to the list of those treatable with its combination of Tecentriq (atezolizumab) and Avastin (bevacizumab): unresectable hepatocellular carcinoma (HCC). Both medicines originated at Genentech Inc.
HONG KONG – Following FDA approval of its IND, Israel-based Kahr Medical Ltd. is set to start a phase I/II trial of lead product DSP-107, a second-generation CD47- and 41BB-targeting compound. The move puts Kahr among a number of companies working on drugs against checkpoint molecule CD47.
HONG KONG- Boehringer Ingelheim International GmbH and Roche Holding AG have announced new initiatives to seek R&D collaborations in China, increasing both their footprint in China and China’s global biopharma presence. Boehringer Ingelheim announced earlier this month the launch of an External Innovation Hub in Shanghai. Meanwhile, Roche China also launched a collaboration initiative this week to develop therapies for gastrointestinal cancer.
HONG KONG- Boehringer Ingelheim International GmbH and Roche Holding AG have announced new initiatives to seek R&D collaborations in China, increasing both their footprint in China and China’s global biopharma presence. Boehringer Ingelheim announced earlier this month the launch of an External Innovation Hub in Shanghai. Meanwhile, Roche China also launched a collaboration initiative this week to develop therapies for gastrointestinal cancer.
A key opinion leader (KOL) consulted by SVB Leerink deemed Roche Holding AG’s anti-TIGIT drug results “really huge” and “quite amazing,” affirming the Basel, Switzerland-based firm’s lead in the field. The phase II data from the study known as Cityscape rolled out at the virtual American Society of Clinical Oncology (ASCO) meeting.
In data taken from three expansion cohorts of Exelixis Inc.’s phase Ib study of Cabometyx and Tecentriq in patients with locally advanced or metastatic solid tumors, a 27% objective response rate was seen in those with immune checkpoint inhibitor-pretreated non-small-cell lung cancer.
HONG KONG – In one of the latest combination efforts against cancer, Kahr Medical Ltd. is teaming up with Switzerland's Basel-based Roche Holding AG to study the use of the former's lead program, DSP-10, in combination with the latter's PD-L1-blocking checkpoint inhibitor, Tecentriq (atezolizumab), in patients with advanced non-small-cell lung carcinoma refractory to checkpoint inhibitors.
