iOnctura has begun a randomised phase 1/2 study investigating its lead asset, roginolisib, in combination with dostarlimab, with or without docetaxel, in advanced non-small cell lung cancer (NSCLC).

The first patient has been dosed in the study, which aims to evaluate the safety of the drug combination and its potential in overcoming resistance to standard immunotherapy.

NSCLC is the most common type of lung cancer and accounts for around one in five cancer deaths globally. Current standard treatments include anti-PD-L1 or anti-PD1 immunotherapy, with or without chemotherapy, but many patients experience resistance over time.

iOnctura’s study will assess whether targeting PI3Kδ could re-invigorate the immune system, preventing or reversing treatment resistance.

Michele Maio, professor of medical oncology and primary coordinating investigator of the study said: "There is a significant lack of treatment options for NSCLC patients who have progressed on immunotherapy and chemotherapy.

"We will be investigating whether the combination of roginolisib with dostarlimab and +/- chemotherapy can be given safely and may provide a novel treatment option in patients who no longer respond to their current treatment."

Emerging data suggests that combining roginolisib with an anti-PD-L1/PD1 agent may help combat drug resistance in NSCLC while maintaining safety. Under a supply agreement, GSK will provide dostarlimab for the trial, while iOnctura retains worldwide rights to roginolisib.

Eisai Europe and Biogen Idec have announced the validation of a Marketing Authorisation Variation by the Medicines and Healthcare products Regulatory Agency (MHRA) for lecanemab – marketed as Leqembi®, in the UK.

The proposal aims to reduce the intravenous (IV) dosing frequency from every two weeks to every four weeks, following the initial 18-month treatment period at the approved fortnightly dose. This could provide greater flexibility for eligible adult patients with early Alzheimer’s disease (AD) and their healthcare providers.

The MHRA will now evaluate the application to decide whether to approve or reject this variation.

Lecanemab, currently licensed as a biweekly 10 mg/kg IV infusion, is developed by Eisai and Biogen to address the unmet needs of AD patients. AD, a chronic, progressive disease and the UK’s leading cause of death, often begins with symptoms such as memory loss and progresses to impair independence and daily activities.

The proposed change is part of Eisai and Biogen’s broader commitment to developing innovative solutions for managing AD, easing treatment burdens, and improving patient care. Eisai leads regulatory submissions for lecanemab globally, while both companies co-promote the treatment in the UK.

If approved, the monthly maintenance dosing could enhance treatment accessibility and flexibility, helping healthcare systems manage this complex disease more effectively. The MHRA decision is highly anticipated by clinicians and patients alike.