Oncology

The Swiss major’s CDK4/6 inhibitor has met the primary endpoint in a Phase II trial in first-line aggressive advanced breast cancer, supporting off-label use as the firm goes head to head with Pfizer’s rival drug Ibrance.

Nkarta has updated its early results for its natural killer cell therapy, where it has shown promising efficacy and potentially superior safety to existing CAR-Ts.

The German biotech announced in March that it was terminating the early-stage oncology R&D projects that came with its purchase of Constellation last year and Novartis has snapped up one of them.

Yuhan’s oncology drug lazertinib is set to expand its indications in Korea to the first-line treatment of EGFR mutation-positive advanced NSCLC, based on new top-line Phase III data showing clinical benefits for all patient sub-groups.

The major’s radioligand therapy has succeeded in an earlier line of prostate cancer therapy that presents a large market opportunity, but some observers are keen to see full data before raising their sales projections.

In this week's podcast edition of Five Must-Know Things: safety debate as more lecanemab data reported; amyloid discussions continue at Alzheimer’s meeting; China COVID unrest affect country’s biotech sector; and Merck’s CMO talks about post-Keytruda plans.

The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.

Rezlidhia, which was only recently licensed by Rigal from Novo Nordisk-owned Forma Therapeutics, should challenge the market dominance of Servier's Tibsovo in the IDH-1 inhibitor subset of acute myeloid leukemia patients. 

GSK’s PD-1 inhibitor will not be able to make up much ground on Keytruda, but new studies suggest it is a match for the market-leading PD-1 inhibitors.

Without disclosing data, Nimbus announced positive Phase IIb results for NDI-034858 in psoriasis. The company plans to initiate a Phase III trial next year.

Deal Snapshot: German firm gets license rights to Ryvu’s STING agonist portfolio in addition to collaborating on immunomodulators. Ryvu adds need cash via upfront and equity payments from BioNTech.

The move marks the second time since last year that Roche has withdrawn a urothelial carcinoma indication after its confirmatory trial failed to show an overall survival benefit.