Clinical Trials

The French firm has followed up its recent acquisition of Swiss lung cancer specialist Vertical Bio by signing a pact with Vernalis.

The Swiss pharma giant is building momentum in radiopharmaceuticals by racking up positive pivotal trial data and overcoming manufacturing bottlenecks.

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.

A positive showing by Bristol Myers Squibb’s checkpoint inhibitor Opdivo in non-small cell lung cancer could broaden its use, though much depends on the magnitude of the hit.

With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval plus a move into first-line therapy.

The announcement that LEAP-006 and LEAP-008, both in non-small cell lung cancer, did not meet their primary endpoints adds to a string of failures for the combination.

Once again choosing their words carefully, the partners talk only of ‘plans’ to file as regulators will first have to clarify when overall survival data will be required for the new antibody-drug conjugate in breast cancer.

The liver disease is one of the hottest areas of drug development. Here are some upcoming catalysts to look out for.

The company said the “totality of data” from the confirmatory PROTECT trial in IgA nephropathy showed the drug slowed decline in kidney function.

With a pair of Phase III setbacks due to high placebo response, Relmada reports positive efficacy and safety data from an open-label trial while awaiting data from two ongoing pivotal studies for REL-1017, an NMDA antagonist.

The company blamed lack of funding for incomplete enrollment of the Phase II study in acute suicidal ideation and behavior in major depressive disorder, saying it would have reached statistical significance had it fully enrolled.

RayzeBio's IPO and Genentech's first buy-in into the field show a wave of next-generation companies hoping to expand the radiopharmaceutical field.

Despite the astounding efficacy and commercial potential of incretins in obesity, many groups are trying different mechanistic approaches to the disease – if only to enable combinations. 

In this week's podcast edition of Five Must-Know Things: Biomarin’s next chapter; Amgen’s obesity plans; Daiichi’s new ADC data; Acelyrin hit by clinical failure; and Skyrizi beats Stelara in Crohn’s.

With a Phase II study stopped for efficacy in bleeding reduction, Anthos hopes to bring abelacimab, a dual Factor XI/XIa inhibitor to market to prevent strokes in a-fib patients and to treat cancer patients with thrombosis.

Research shows bringing trials to community oncology centers remains a daunting task, but Verily and OneOncology aim to help with new clinical trial management software. In other trial news, MindBio’s LSD goes into Phase II; Erasca starts tumor agnostic program; the Project to Accelerate New Treatments for Tuberculosis launched an international study investigating new combinations; and more.