GSK to take blood cancer drug into late-stage trials
GlaxoSmithKline (GSK) plans to take a blood cancer antibody-drug conjugate into late-stage trials after unveiling new data at this year's ASH conference.
New CEO Emma Walmsley has said finding new cancer drugs is a priority for GSK after her predecessor Sir Andrew Witty sold its approved, and most of its pipeline, oncology drugs to Novartis in a multi-billion dollar asset swap deal in 2014 .
New data on GSK2857916 in heavily pre-treated multiple myeloma patients, presented at the American Society for Hematology (ASH) conference, was therefore hotly anticipated.
The FDA granted GSK2857916 Breakthrough Therapy status, meaning that the FDA will expedite development and could grant a faster six-month review if it still considers it to be a badly-needed medicine.
The European Medicines Agency has also granted GSK2857916 'Priority Medicine' (PRIME) status, where the regulator provides support in development and a faster review.
While data from the anti-B-cell maturation antigen (BCMA) did not have the incredible efficacy seen with CAR-T therapies, it also lacked the extreme side effects, and GSK said it was planning pivotal studies next year.
In the 35-patient phase 1/2 DREAMM-1 study, monotherapy with GSK2857916 showed a 60% response rate and a median progression-free survival of 7.9 months.
The most commonly-reported adverse events were corneal events (63%) and thrombocytopenia (57%); no dose-limiting toxicities were reported.
Infusion-related reactions (IRRs) occurred in 23% of patients (without pre-medication) on the first infusion and no IRRs occurred on subsequent infusions.
Study participants were heavily pre-treated, with 57% having at least five prior lines of treatment and 40% having prior treatment with J&J’s Darzalex (daratumumab).
The study consists of two parts: a dose escalation phase in which patients received GSK2857916 at increasing doses, and a dose expansion phase in which all patients received GSK2857916 at the recommended phase 2 dose. Results from the dose escalation phase of the study were presented at last year’s ASH.
[caption id="attachment_29524" align="alignnone" width="238"] GSK's Axel Hoos[/caption]
Axel Hoos, senior vice president of oncology R&D at GSK, said: “The patients participating in the DREAMM-1 trial had very limited options for further treatment, so we are encouraged by the response rate seen in this trial.
"GSK2857916 is the leading asset in our emerging pipeline of potentially transformative oncology medicines and we plan to rapidly progress its development programme, initiating pivotal monotherapy studies as well as new combination studies in 2018.”