Eli Lilly and Innovent Biologics will face an FDA advisory committee for their PD-1 application in lung cancer. Takeda and Bayer put to rest their hemophilia patent infringement lawsuit. Novo Holdings led a $125 million series C in Singapore's Hummingbird Bioscience. And more.
May 19, 2021 5:00pm
Roche s Tecentriq cut the risk of post-surgery cancer recurrence or death by 34% against best supportive care in patients with PD-L1-postivie stage II to IIIA non-small cell lung cancer. (Roche)
In early cancer that’s amenable to surgery, a field viewed as the next battleground for PD-1/L1 immunotherapies, Roche’s Tecentriq has claimed the first win in non-small cell lung cancer. But the drug’s role, at least in some patients, remains unclear.
Tecentriq slashed the risk of cancer recurrence or death after surgery by 34% in a study slated for the virtual American Society of Clinical Oncology meeting next month but only in patients with stage II to IIIA disease whose tumors bore the PD-L1 biomarker.
(Aquila)
In the first data drop for the drug, I-Mab has some early positives from a phase 1 trial of its CD73 antibody uliledlimab when wedded to Roche’s Tecentriq.
China’s I-Mab made headlines over the past year for a huge $418 million raise followed swiftly by a $2 billion biobucks pact with AbbVie for its other pipeline asset lemzoparlimab, the biotech’s anti-CD47 monoclonal antibody, which AbbVie is also eyeing as a potential combination med with the blood cancer drug Venclexta.
The data out at ASCO next month, with a peek today via its abstract, isn’t for that drug but rather for I-Mab s earlier effort, the CD73 antibody uliledlimab, from a small phase 1 trial that combined the drug with Roche’s PD-1 checkpoint inhibitor Tecentriq.
Dive Brief:
Merck & Co. s immunotherapy Keytruda kept tumors from returning in a Phase 3 study of patients with a tough-to-treat form of early-stage breast cancer, positioning the drugmaker to again seek approval after regulators rejected the treatment earlier this year.
Merck didn t detail the results from the study, known as Keynote-522. According to the pharma, a regimen of Keytruda and chemotherapy administered before surgery, and then Keytruda alone afterwards, kept patients disease from returning for longer than chemotherapy. Similar findings have supported other recent approvals of immunotherapies in early cancers.
Keytruda had a chance to become the first immunotherapy approved in triple-negative breast cancer. But a Food and Drug Administration advisory panel in February voted unanimously to recommend the agency wait for more data from Keynote-522 before clearing its use, leading the regulator to follow up with a rejection.