Interesting article Ahjay. Clearly of interest to us is the...

Interesting article Ahjay. Clearly of interest to us is the discontinued HNSCC trial with Keytruda

From ENDPOINTS NEWS April 14, 2021
By John Carroll
Editor & Founder



Following a recommendation from the Independent Data Monitoring Committee, GSK has discontinued treatment in the INDUCE-3 trial — which was used in combination with Keytruda for advanced or metastatic head and neck squamous cell carcinoma.

Also on the chopping block is INDUCE-4 phase, which also used a combination with Keytruda plus chemo.According to GSK:The totality of the data will be evaluated to assess the impact on the overall clinical development programme for feladilimab.

Which doesn’t sound promising.Barron was brought in to revive GSK’s oncology hopes, but has run into a number of setbacks along the way. It’s a particularly difficult failure for 2021, as Barron and GSK CEO Emma Walmsley have promised to deliver solid evidence of a turnaround in the pipeline this year.
This latest issue follows the February flop for bintrafusp alfa, and another failure is making analysts like Geoff Porges at SVB Leerink restless.

GSK’s growth in oncology now depends strongly on new indications for marketed drugs with little visible upside from their late-stage pipeline.

Blenrep (anti-BCMA antibody-drug conjugate mAb) is currently being evaluated in second line multiple myeloma with results expected in 2022-2023, and Zejula (PARPi) entered a pivotal phase 3 trial (“ZEAL-1L” in non-small cell lung cancer (NSCLC) which has a primary completion date in early 2024. Both these medicines have significant limitations compared to competition and are unlikely to generate much interest or excitement among investors. Were it not for GSK’s weak balance sheet, and the calls on their cash flows heading into their long-anticipated consumer separation, we would be suggesting that the company must become more active in larger scale business development. Investors are likely to start to question management about the viability of the spin out strategy, and may alternatively suggest separating out the vaccine business, which we regard as the most valuable and most discrete part of their portfolio.