Friday Five - The pharma week in review (16 May 2019)

ASCO approaching

With the world's largest oncology medical conference a matter of weeks' away, abstracts released on Wednesday were eagerly digested by analysts and investors.

Among the most anticipated data are Phase I results for Amgen's KRAS inhibitor AMG 510, showing that in nine evaluable patients with solid tumours, one subject had a partial response, six participants had stable disease and two had progressive disease.

KRAS mutations are thought to occur in around a quarter of all cancers (and around 14 percent of all lung cancers), but it had long been assumed the cell signalling protein was an unsuitable drug target. In overcoming these complexities, Amgen has described AMG 510 as an elegant molecule, though more data are necessary to fully validate this approach.

And Amgen is not the only company targeting KRAS mutations. Mirati Therapeutics is developing its own oral KRAS inhibitor MRTX849 in non-small-cell lung cancer and colorectal cancer; like AMG 510, it is currently in Phase I testing; while Merck & Co. and Moderna have this week initiated a Phase I trial for a KRAS mRNA vaccine, as a monotherapy and in combination with Merck's Keytruda.

Unlike Amgen and Mirati's drugs, which are targeting a singular mutation known as G12C, the vaccine will encode for four common mutations. As Evercore ISI analyst Umer Raffat notes, unlike AMG 510 and MRTX849, which bind to the mutant protein and disrupt its activity, Merck and Moderna’s vaccine is "intended to raise an immune response against any cell harbouring that mutation."

See also - ASCO19: Roche's entrectinib shrinks tumours in children, adolescents with NTRK, ROS1 or ALK gene fusions

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Johnson & Johnson's blockbuster aspirations

Wednesday also saw Johnson & Johnson provide a review of its pharmaceutical business, which included an updated outlook for the late-stage pipeline.

The company's roster of new drug approvals through to the end of 2023 should include 10 blockbuster products, including the recently approved drugs Spravato (for treatment-resistant depression) and Balversa (in bladder cancer).

Expectations for the latter are supported by feedback from oncologists recently polled by FirstWord, most of whom perceive Balversa to be a practice-changing treatment for a subset of bladder cancer patients.

Newly highlighted drugs for investors and competitors to keep an eye on include bispecifics being developed for the treatment of multiple myeloma (JNJ-7564 and JNJ-7957), myeloid malignancies (JNJ-9178 and JNJ-1244), EGFR and cMET altered tumours (JNJ-6372), and the third-generation EGFR inhibitor lazertinib.

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Baby steps for Merck KGaA

Feedback from our latest Physician Views poll suggests Mavenclad may struggle to compete in the US multiple sclerosis market; disappointing news for Merck KGaA, which this week indicated that it expects global sales of the drug to peak at between $1 billion and $1.5 billion.

The company is plotting a renaissance for its pharmaceutical business and also saw its PD-L1 inhibitor Bavencio (co-developed and co-marketed with Pfizer) approved for the treatment of first-line renal cell carcinoma (RCC) - in combination with Pfizer's targeted therapy Inlyta - this week.

Whether this combination can gain material share from Bristol-Myers Squibb's pairing of Opdivo and Yervoy, and Merck & Co.'s Keytruda/Inlyta combination remains to be seen, however.

The latter provides the more obvious comparator, but unlike Merck's Keytruda regimen, the pairing of Bavencio and Inlyta has yet to demonstrate an overall survival advantage - though data are trending in the right direction - it also looks like a weaker regimen in terms of overall response rate, complete response rate and progression-free survival.

This puts onus on a successful revitalisation of Merck KGaA's R&D pipeline on a number of other emerging cancer assets, one of which - its bi-functional fusion protein immunotherapy M7824 - is now being co-developed with GlaxoSmithKline.

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Key drug battlegrounds

With first-quarter earnings season drawing to an end, we took a closer look at how some of Big Pharma's important drug franchises are faring in key disease-area battlegrounds.

In the PD-(L)1 inhibitor market, for instance, Keytruda continues to pull away as the clear market leader with this trend potentially accelerating if adoption in the aforementioned first-line RCC segment is strong.

More here

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Anticipation grows for Zolgensma

Ahead of what is widely expected to be this year's most notable new drug approval, FirstWord spoke to a leading key opinion leader in the field of spinal muscular atrophy (SMA) to get the low down on what lies ahead for Novartis' gene therapy Zolgensma.

She told FirstWord that although the rapid emergence of new potential therapies for SMA is highly encouraging, it is Novartis' potential 'one time' treatment that is attracting the most interest among families with children diagnosed with the condition.

More here

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