Friday Five – the pharma week in review

GlaxoSmithKline banks on PARP success to revive cancer aspirations; Hopes dim further for AbbVie's Rova-T; The best of ASH; Roche looks well positioned for SCLC success, says expert; Johnson & Johnson the latest player to step up its interest in AML

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GlaxoSmithKline banks on PARP success to revive cancer aspirations

GlaxoSmithKline has said it will acquire Tesaro for $5.1 billion to once again become a commercially active player in the oncology market. It will need to convince sceptical investors that this is a good deal.

Broadly speaking, success could largely be determined if GlaxoSmithKline is right in thinking that an emerging new class of therapies - PARP inhibitors - remains undervalued. Demonstrating that PARPs, such as Tesaro's Zejula - can consistently be used across multiple tumour types in a broad number of patients (not just those with a specific mutation) will be critical.

Onus will sharpen next year on the read out of Tesar'’s PRIMA study, which is evaluating Zejula as a first-line maintenance therapy in ovarian cancer patients.

Analysis - ViewPoints: GlaxoSmithKline pulls the M&A lever to move back into oncology, and looks to get one over on AstraZeneca.

AstraZeneca and Merck & Co. recently showed that PARP inhibitors are poised to change the treatment paradigm in this setting, though ground breaking data for their product Lynparza was shown in BRCA mutation tumours; found in around 15 percent of newly diagnosed ovarian cancer patients. GlaxoSmithKline is banking on PRIMA showing a compelling effect in all-comer patients, which would open up a much larger commercial opportunity.

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Hopes dim further for AbbVie's Rova-T

Investors will be hopeful that the acquisition of Tesaro could spark an upturn in M&A activity, though another setback for AbbVie's experimental cancer product Rova-T this week may prompt continued caution.

Rova-T was the centrepiece of AbbVie's $5.8-billion acquisition of Stemcentrx in 2016, but has so far failed to live up to expectations. In March, the company said it was no longer seeking accelerated approval for relapsed/refractory small-cell lung cancer (SCLC) based on Phase II results and this week confirmed enrolment in a study for second-line SCLC has been halted after an interim analysis showed survival rates were shorter in the Rova-T arm.

Analysis - ViewPoints: AbbVie’s hopes on Rova-T look increasingly like a Hail Mary.

SCLC remains a challenging disease for drugmakers (see Roche looks well positioned for SCLC success, says expert, below).

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The best of ASH

FirstWord was in attendance at the annual meeting of the American Society of Hematology (ASH) this weekend.

Editor Becky Simon caught up with Allogene to discuss their potential first-to-market allogenic (or 'off the shelf') CAR-T therapy and took a closer look at the opportunity for bispecific antibodies in multiple myeloma - see also ViewPoints: Bispecific coming out party at ASH puts CAR-Ts on notice.

CAR-T therapies were once again a prominent feature at ASH; new ways to improve patient safety with existing CAR-T products was up for discussion, bluebird bio discussed with us their follow-on BCMA CAR-T bb21217 and Johnson & Johnson made the case in favour of LCAR-B38M, the potential competitor product it in-licensed from Legend Biotech last year.

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Roche looks well positioned for SCLC success, says expert

Roche confirmed this week the FDA has granted priority review status to its regulatory application for the PD-L1 inhibitor Tecentriq for the first-line treatment of small-cell lung cancer (SCLC).

In September at the World Conference on Lung Cancer (WCLC), Roche showcased data from its IMPower133 study showing a median two month overall survival benefit for the combination of Tecentriq and chemotherapy versus chemotherapy alone.

The subsequent failure of Bristol-Myers Squibb's competing PD-1 inhibitor Opdivo to show a survival benefit in relapsed SCLC in October illustrates the challenging nature of this indication.  Roche therefore has a significant opportunity to grow market share, one expert told FirstWord this week. He believes that data from IMPower133 has set a bar that other immunotherapies may struggle to beat or match.

See - KOL Views Results: Bristol-Myers Squibb’s missteps in SCLC could mean a big win for Roche.

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Johnson & Johnson the latest player to step up its interest in AML

The market for novel acute myeloid leukaemia (AML) therapies has exploded into life over the past two years, with no fewer than eight new drug approvals - see ViewPoints: Five key trends to watch in AML.

Looking to get in on the act, Johnson & Johnson agreed this week to part with $300 million upfront to in-licence argenx's experimental anti-CD-70 antibody cusatuzumab.

This antibody is being lined up as a potential competitor to AbbVie and Roche's recently approved Venclexta, in newly diagnosed AML patients who are unfit for intensive chemotherapy.

Argenx confirmed this week that in the Phase I portion of its ongoing Phase I/II study, cusatuzumab demonstrated an impressive complete remission rate of 91 percent - albeit in a small number of patients (10 of 12) - up from 75 percent from a data cut made last month.

Although these data are early, they bested Venclexta's high response rate, noted analysts at Nomura.

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