GSK Upbeat On RSV Vaccines, Hepatitis B Therapy
Walmsley Flags Future Growth Drivers
Executive Summary
GlaxoSmithKline's executive team outlined the progress the company is making against COVID-19, lupus nephritis, ovarian cancer and multiple myeloma.
GlaxoSmithKline plc’s candidate RSV vaccines and the hepatitis B therapy, GSK 3228836, were singled out by CEO Emma Walmsley during the company’s third-quarter briefing for analysts on 28 October.
Both candidates, which are in late-stage clinical trials, “represent major opportunities for health care impact and have the potential to be significant future growth drivers,” said Walmsley, who has made the strengthening and advancing of GSK’s R&D pipeline one of her priorities.
After long periods without new product launches, GSK is now starting to commercialize several new therapies – the HIV therapy, Rukobia (fostemsavir), was approved in the middle of this year, and the BCMA-targeted multiple myeloma therapy, Blenrep (belantamab mafodotin), was approved for marketing in the US and EU during the third quarter. (Also see "GSK’s Blenrep Wins BCMA Race, Carries Ocular Toxicity Warning" - Scrip, 6 Aug, 2020.) and (Also see "GSK To Address Multiple Myeloma With First-In-Class Blenrep In EU" - Scrip, 27 Aug, 2020.)
GSK’s president of global pharmaceuticals, Luke Miels, noted the IL5-directed therapy, Nucala (mepolizumab), has been submitted for the treatment of nasal polyps in the US, and studies in chronic obstructive pulmonary disease are ongoing. Submissions for three additional indications - hypereosinophilic syndrome, chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis - have also just been accepted by the European Medicines Agency.
Approval is expected by the end of the year for use of systemic lupus erythematosus drug Benlysta (belimumab) in the additional indication, lupus nephritis, Miels said during the analysts briefing. The product is also being evaluated in combination with rituximab in the BLISS-BELIEVE study, and “if successful could potentially lead to clinical remission,” he added.
In the third quarter, GSK started the ZEAL-1L study of a combination of the PARP inhibitor, Zejula (niraparib), with pembrolizumab (Merck & Co’s Keytruda) for maintenance therapy in both squamous and non-squamous non-small cell lung cancer.
COVID Candidates
GSK’s chief scientific officer Hal Barron said he was excited about the potential of the “very special” anti-COVID-19 antibody program, VIR-7831/GSK4182136, and also singled out the promise of GSK’s candidate anti-PD-1 monoclonal antibody, dostarlimab.
VIR-7831, which GSK is developing in a collaboration with the originator, Vir Biotechnology, Inc., is “very unique, for a number of reasons,” Barron told analysts. He highlighted its long duration of action and its potential to destroy cells infected with the virus; Vir and GSK are also working on a follow-on antibody, VIR-3872, with an enhanced effector function, which may enter clinical trials this year (see sidebar).
Miels was also upbeat about VIR-7831 during the briefing, underlining its potential to be a first-in-class asset, with a unique receptor binding site which is highly conserved and required for viral entry into the host, which may represent a high barrier to the development of resistance.
The COMET-ICE study of VIR-7831 in the early treatment of COVID-19 patients at high risk of hospitalization is ongoing, with data expected to be available by the end of the year, and the company is planning to expand studies to include hospitalized patients and for use in prophylaxis.
GSK’s anti-PD-1 inhibitor, dostarlimab, which is in late-stage clinical development, “is a nice complement to our pipeline, and we’re very excited about its activity,” Barron commented, adding that its once every six weeks dosing could be an “attractive attribute.” Dostarlimab has been submitted for approval in the EU for the treatment of patients with recurrent or advanced mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) endometrial cancer. (Also see "EU Fast-Track Loss For GSK's Dostarlimab" - Pink Sheet, 19 Aug, 2020.)
Zejula has just been approved by the European Commission as first-line monotherapy maintenance treatment in patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy, the company announced on 29 October. It is thus the only PARP inhibitor approved in the EU for use as a monotherapy in patients with advanced ovarian cancer, regardless of their biomarker status. In April 2020, Zejula was approved in the US for the same indication.