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GSK upbeat on its return to oncology market

Zejula signals comeback after four year hiatus

Zejula

GlaxoSmithKline’s chief executive Emma Walmsley says it can be competitive in oncology in 2019 and beyond, despite having exited the market nearly four years ago.

Presenting to investors at the JP Morgan healthcare event earlier this week, Walmsley and her team indicated that cancer would be a key driver for growth in the coming years.

It has a lot of ground to make up in the industry’s biggest and most competitive sector, however, after previous CEO Sir Andrew Witty made the decision to trade all its marketed cancer treatments in the 2015 asset swap with Novartis.

That’s why Walmsley and her team decided to splash out $5.1bn on the acquisition of cancer specialist firm Tesaro last month, gaining with it the PARP inhibitor treatment Zejula.

An even bigger deal unveiled in December was the creation of a new consumer health joint venture with Pfizer, which will eventually see the division spun out from GSK, leaving it a ‘pure play’ pharma and vaccines company.

This is what many investors have been calling for several years – however the market remains somewhat underwhelmed by GSK’s overall prospects for growth over the next few years.

GSK faces generic competition to its biggest seller, ageing respiratory treatment Advair, by the end of 2019, and analysts believe the company’s HIV franchise could decline thanks to competition from rivals Gilead and others.

Nevertheless, there is expected to be strong performances from its Shingrix vaccine and next-generation respiratory drug Ellipta, which have both been the focus of GSK’s new drive towards commercial excellence.

Can GSK make Tesaro assets shine?

Analysts are sceptical that Zejula can make up ground on its biggest rival, Lynparza, the runaway market leader co-marketed by AstraZeneca and Merck & Co, with another rival Clovis’ Rubraca, also competing in the market.

Challenged by one analyst at JP Morgan that Lynparza was ‘miles ahead’, Walmsley and her commercial chief Luke Miels responded by saying that topline results from Zejula’s PRIMA trial could be a game-changer.

Due for readout in late 2019, the PRIMA trial is looking at Zejula in first line ovarian cancer, regardless of any biomarker status.

Luke Miels

Luke Miels

Luke Miels says a positive result in this trial could see Zejula reaching a far wider patient population than Lynparza, which gained first line FDA approval in germline BRCA-mutated patients in December.

“It’s great that they have had an early read out in first line ovarian, but there is really very limited overlap. If we have a similar readout, we’ll have a much larger opportunity there.”

New R&D chief Hal Barron was also on hand to underline the clinical potential of the PARP inhibitor class, including benefitting patients with other mutations.

Hal Barron

Hal Barron

He said the potential of PARP inhibitors has been underestimated so far, with the class being ‘pigeonholed’ as only being of benefit of to BRCA patients.

Of greatest potential are those with BRCA wild-type tumours and patients with homologous recombination deficiency (HRD) - the latter expressed in 35% of ovarian cancer patients, compared to the 15% with germline BRCA.

Barron said HRD might prove a good target in other tumours, including lung cancer, though a better tissue diagnostic was needed.

Along with Zejula, Tesaro also brings with it a pipeline PD-1 inhibitor, TSR-022. Barron says this didn’t drive the acquisition, but said it would help GSK develop its own in-house immunotherapy combinations, as well as being in development for endometrial cancer.

The company already has Zeluja in combination trials with TSR-022, with all the established PD-1 players also pursuing similar PARP inhibitor combinations.

GSK’s other big hope in oncology is its BCMA antibody-drug conjugate (GSK2857916), being studied in multiple myeloma, which could reach the market as early as 2020.

Article by
Andrew McConaghie

10th January 2019

From: Sales

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