Friday Five – The Pharma Week in Review (26 November 2021)

Roche's big ASH reveal

Late-breaking abstracts for next months' annual meeting of the American Society of Hematology (ASH) have been published.

They include data from the POLARIX study showing that the combination of Roche's antibody-drug conjugate (ADC) Polivy with R-CHP improved progression-free survival (PFS) by 27% versus R-CHOP as a first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL).

Analysts at Credit Suisse describe the PFS advantage as potentially practice changing, though detailed results are necessary to ascertain whether higher-risk patients were primarily responsible for the benefit demonstrated. Furthermore, the POLARIX plus R-CHP regimen has yet to show an overall survival advantage.

BMS hit by mavacamten delay

Bristol Myers Squibb announced late last week that the FDA extended its review of a filing seeking approval of mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy by three months to April 28 next year. According to the company, the review has been extended to assess additional information related to updates to the proposed risk evaluation mitigation strategy (REMS).

Approval of mavacamten is critical in justifying Bristol Myers Squibb's $13-billion acquisition of MyoKardia in 2019, with a competitor therapy from Cytokinetics also moving into late-stage development.

Confirmation of a REMS programme will come as a something of a surprise given that mavacamten has not been associated with any major safety concerns, though it does speak to the short duration of the pivotal-stage EXPLORER-HCM study, with the FDA likely concerned at the current lack of long-term follow up data.

Merck & Co.'s HIV aspirations hit a bump in the road

Clouds have gathered over a promising HIV drug in Merck & Co.'s late-stage pipeline, with the company exploring whether the nucleoside reverse transcriptase translocation inhibitor islatravir causes immune cell counts to decline.

Whilst it is far from conclusive at this juncture whether development of islatravir will be abandoned due to safety concerns, this disclosure is a blow to investor sentiment towards the company's R&D pipeline, which is largely viewed as lacking compelling late-stage assets versus many of Merck's key competitors.

It has also proven sufficient enough for Gilead Sciences to temporarily pause clinical studies evaluating islatravir in combination with its capsid inhibitor lenacapavir, which are ongoing under a collaborative agreement signed between the two companies earlier this year.

J&J outlines cancer credentials

Johnson & Johnson's recent R&D investor presentation highlighted both multiple myeloma and EGFRm non-small-cell lung cancer (NSCLC) as areas where the company expects to make significant strides over the next decade.

FirstWord spoke to Janssen's global head of oncology Peter Lebowitz about how the CAR-T therapy cilta-cel could redefine the first-line treatment of myeloma and why its bispecific antibody Rybrevant and the EGFR tyrosine kinase inhibitor (TKI) lazertinib are under-appreciated assets in the company's pipeline.

Arrowhead snags GSK as new NASH partner

GlaxoSmithKline is in need of some pipeline hits and has thrown its hat into the bent, but unbroken, NASH ring, where a succession of clinical readouts in recent years have tempered commercial expectations for this disease.

In doing so it has teamed up with Arrowhead Therapeutic at an upfront cost of $120 million to co-develop an RNAi therapeutic in markets outside of mainland China.

Arrowhead is one of two RNAi players – the other is Alnylam Pharmaceuticals – focused on targeting HSD17B13, a gene in which lack-of-function mutations have been identified as conferring a 30% to 50% reduction in the risk of developing alcoholic hepatitis, cirrhosis and NASH. Both companies have moved into early human testing with antisense programmes designed to essentially mimic the genetic variants by significantly reducing HSD17B13 mRNA levels, which will hopefully have a similarly protective effect on liver health.

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