Research & Development

Adding oleclumab and monalizumab to the PD-L1 inhibitor improved PFS, while another study showed improved real-world outcomes.

In the absence of head-to-head data, the results from a "matching-adjusted indirect comparison" suggest favorable efficacy of the German group's treatment for solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion when compared with competitor Rozlytrek from Roche.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Amgen’s KRAS G12C inhibitor in combination with the company’s Vectibix generated a 27% overall response rate, nearly tripling the responses seen with Lumakras monotherapy in colorectal cancer.

AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.

Phase III sub-analyses presented at ESMO show the drug providing a survival benefit in a complex subpopulation, as well as improvements to quality of life.

With big oncology losses largely in the rearview mirror, Roche is trying to sell investors on its next wave of cancer drugs; R&D overview pushes message of pipeline renewal.

The Phase III failure of ampreloxetine in nOH followed disappointing Phase IIb data for izencitinib in ulcerative colitis in August. Theravance narrows focus to respiratory disease, including label expansions for Yupelri.

An expert pointed out that XLMTM patients are already at high risk, but if linked to therapy toxicity, the death could doom the ASPIRO trial.

Management updated investors on M&A strategy, US drug pricing reform and R&D investment.

Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.

The Israeli biotech announced disappointing Phase II/III data for opaganib while expanding its Phase II/III RHB-107 study. Pharming unveiled promising data from a company-sponsored study, but an imbalance in an investigator-led study confounded results, while CalciMedica built on the case for its drug as a treatment for COVID-19 pneumonia.