Friday Five - This week's key news stories

Bristol-Myers Squibb bets on TMB

Pushing hard to make up ground on competitors, Bristol-Myers Squibb confirmed this week that its combination of Opdivo and Yervoy showed a significant progression-free survival (PFS) benefit versus chemotherapy in first-line metastatic non-small-cell lung cancer patients. The results are from Bristol-Myers Squibb's much anticipated CheckMate-227 trial.

Simultaneously, however, the company announced for the first time that it has changed the design of CheckMate-227, most significantly to include a cohort of patients who were tested for PFS by tumour mutation burden (TMB) status. The combination hit against this co-primary endpoint, but confusingly, overall survival data will be gleaned from a separate patient cohort, which will be selected by PD-L1 status. These results are expected in late 2018 or early 2019.

Analysis - ViewPoints: Bristol-Myers Squibb hedges its bets on a new biomarker in lung cancer.

Bristol-Myers Squibb appears hopeful of securing approval of the Opdivo/Yervoy pairing on the strength of these initial PFS data, but may face problems convincing regulators given that its own survival data will not use the TMB biomarker.

Emergence of TMB status could play a critical role in redefining the treatment landscape for lung and other cancers, though results presented previously from other studies have shown a lack of overall survival benefit in high TMB patients who did initially appear to benefit from longer PFS. In short, more data is needed.

Gilead pivots back to HIV 

Conceding that sales from its hepatitis C portfolio will decline faster than analysts expect this year (see ViewPoints: Gilead plays up its downside), Gilead Sciences was at least able to confirm approval of its newest HIV therapy - Biktarvy - this week. Consensus models peak sales of around $6 billion, though at least one analyst suggests revenues nearer $10 billion are feasible.

Performance of Biktarvy will have significant implications for GlaxoSmithKline (see ViewPoints: Gilead casts further uncertainty on GlaxoSmithKline's outlook). Though the UK drugmaker claims its own brand Tivicay is the best-in-class integrase inhibitor, analysts expect growth for GlaxoSmithKline's HIV portfolio to slow as a result of Gilead's new launch.

To add a further twist, upon approval of Biktarvy, ViiV Healthcare (the HIV business GlaxoSmithKline holds a majority stake in) filed a patent infringement lawsuit against Gilead, seeking royalties on sales of Biktarvy.

Prescribers who were surveyed by FirstWord last year said that it is Gilead's backbone therapies in the Biktarvy fixed-dose combination that will be key to its success at the expense of Tivicay and Triumeq (Physician Views Poll Results: 'Show a little backbone' – Gilead's existing HIV drugs critical to adoption of newbie bictegravir), whilst a more recent poll indicates that GlaxoSmithKline's recently launched dual therapy Juluca is unlikely to have much impact in limiting use of Biktarvy (Physician Views Poll Results: ViiV's Juluca faces an uphill task).

Xtandi and apalutamide go head-to-head

At this week's ASCO Genitourinary Cancers symposium (February 8-10), data presented for Xtandi (Astellas/Pfizer) and apalutamide (Johnson & Johnson) in non-metastatic castrate-resistant prostate cancer (nmCRPC) is expected to be among the highlights. Results for apalutamide are particularly significant for Johnson & Johnson as it looks to maintain a leading position in the prostate cancer market (its flagship treatment Zytiga is facing imminent patent expiry), but also Pfizer, which inherited Xtandi through its acquisition of Medivation two years ago - ViewPoints: Data confirm apalutamide, Xtandi work in non-metastatic CRPC – but well enough?

We ran the data past oncologists and urologists in our latest snap poll and feedback revealed a number of potential trends to watch assuming these agents are both approved in non-metastatic patients. Quelling some key opinion leader concern, most think top-line results are suggestive of practice changing data, but the market for the agents in earlier-stage patients may not be as large as some analysts are modelling. Perhaps most crucially, if apalutamide is not sufficiently differentiated, physician experience with Xtandi in later lines of therapy could provide to be an important competitive advantage - see Physician Views Poll Results: Breaking down new prostate cancer data with treatment prescribers.

Sanofi - M&A needs must?  

Sanofi's recent deal making - is it part of a trend that will see more consolidation in 2018 versus a lack of activity last year?

Perhaps, though the French company's fourth-quarter results and outlook for this year laid bare its need to acquire additional revenues - see ViewPoints: Sanofi's outlook justifies recent deal making.

Teva stumbles/Allergan glides with migraine disclosures

Teva has added to its recent woes by confirming approval of its CGRP inhibitor monoclonal antibody fremanezumab for the prevention of migraines looks likely to be delayed in the US. Celltrion, which is responsible for manufacturing the product's active ingredient, has received a warning letter from the FDA.

Amgen and Novartis are hoping to secure US approval for their competing CGRP antibody by May at the latest, with Eli Lilly also prepping for an approval later this year. A prolonged delay would see Teva miss out on a first contracting season with US payers and could damage investor sentiment, with shareholders keen to see near-term progress with branded launches. Furthermore, in a crowded market, fremanezumab is differentiated by once quarterly (versus once and twice-monthly dosing for competitor products) administration; a clinical facet that physicians appear receptive to

The market for new therapies to treat acute migraines - including oral CGRP inhibitors - is also poised to be competitive. Allergan laid the first marker this week with positive data from the first of two Phase III trials for its compound ubrogepant - see what neurologists and primary care practitioners thought of this data here.

To read more Friday Five articles, click here.

Reference Articles