Friday Five - The week in review

Data to watch at ASH

The annual meeting of the American Society of Haematology (ASH) takes place this weekend.

AbbVie and Roche will present results from the MURANO trial, which is assessing the combination of Venclexta and Rituxan in relapsed/refractory chronic lymphocytic leukaemia (CLL). Data from a late-breaking abstract shows the combination lowers risk of disease progression or death by 83 percent versus Teva's Treanda and Rituxan; oncologists snap-polled this week by FirstWord are confident these results are practice changing.

In another late-breaking abstract, the combination of Johnson & Johnson's Darzalex with VMP (Velcade, melphalan, prednisone) doubled progression-free survival versus VMP alone in treatment naïve patients ineligible for transplant. One key opinion leader told FirstWord this week these results will drive rapid uptake of Darzalex in the first-line setting.

CAR-T data will also feature prominently at ASH. Novartis will present updated results for Kymriah in diffuse large B-cell lymphoma, where Gilead Sciences' Yescarta has already been approved, while Juno Therapeutics will present data it hopes will position JCAR017 as a potential best-in-class drug.

Juno also announced this week a deal with Eli Lilly to develop CAR-Ts homed against BCMA, a popular target in multiple myeloma development. Bluebird bio – one of the leaders in this particular field – will present Phase I/II data for its Celgene-partnered CAR-T bb2121 at ASH with plans to start a registration-supporting trial imminently. Bluebird will also present data for its sickle cell disease and beta thalassaemia gene therapy LentiGlobin.

AstraZeneca will continue to build its case for Calquence as a best-in-class BTK inhibitor and competitor to AbbVie/Johnson & Johnson's Imbruvica, with data being presented from a number of studies in CLL and mantle cell lymphoma, and GlaxoSmithKline will present early stage data for its BCMA antibody drug conjugate; a drug it hopes will revive its fortunes in oncology development.

Novo Nordisk secures key drug approval

Approved by the FDA on Tuesday, Novo Nordisk's Ozempic is the newest once-weekly GLP-1 agonist to reach the market for type 2 diabetes. Earmarked as the company's key growth driver into the early 2020s, we assessed Ozempic's strengths, weaknesses, opportunities and threats in this product profile.

Roche raises stakes in IO race

Roche presented positive data for its combination of Tecentriq, Avastin and chemotherapy in first-line non-small-cell lung cancer patients at the ESMO-IO congress on Thursday, becoming the first company to publish positive Phase III data for a PD-(L)1/chemotherapy combination.

Merck & Co.'s Keytruda plus chemotherapy has already been approved in the US on the strength of a smaller Phase II trial (Keynote-021), although this is a process the European Medicines Agency is unwilling to replicate (ViewPoints: EMA sheds further light on key Keytruda data in shadow of Roche's big reveal). Roche, therefore, looks well positioned to gain first approval for a chemotherapy-based combination in Europe.

Merck will have to wait for data from its Phase III Keynote-189 study, due to read out in early 2019, before it can refile in Europe and these results will also provide important context for Roche's data from IMpower150.

In the meantime, inevitable comparisons to the available Keynote-021 data are beset with limitations, although appear to broadly suggest a solid performance for Roche's combination. The key question at this juncture is whether the addition of Avastin offers sufficient efficacy benefit versus additional cost and toxicities - see ViewPoints: Merck & Co.'s early-bird data stops Roche from taking flight out of ESMO-IO

Contrasting fortunes in NASH

Contrasting fortunes for two emerging players in the field of NASH (non-alcoholic steatohepatitis) were seen this week.

While NASH is commonly thought of as a complex, multifactorial disease that will likely require a combination approach to abrogate its various underlying pathologies, Madrigal Pharmaceuticals thinks the solution may be simpler, and has initial proof-of-concept data for MGL-3196 that the company believes support its position –  read more here.

Meanwhile, Galectin Therapeutics is putting a subgroup-analysis spin on its new Phase IIb readout in NASH, saying that the response it saw from a subset of cirrhotic patients will justify advancing the compound into Phase III – more here.

Sage doubles up on positive depression data

Sage Therapeutics announced impressive Phase II data for its major depressive disorder therapy SAGE-217 on Thursday, prompting CEO Jeff Jonas to suggest "I think we're looking at a brand new treatment paradigm for depression." Treatment with SAGE-217 was associated with a significant mean reduction in the Hamilton Rating Scale for Depression of 17.6 points, compared to 10.7 for placebo.

Analysts at Leerink described data from the randomised Phase II trial as a best-case scenario, noting that "with the caveat of cross-trial comparisons, this difference (reduction in HRS-D versus placebo) is both larger – and attained faster – than what's observed for other antidepressants today."

Positive data follows Sage's recent Phase III success in postpartum depression (KOL Views Results: Leading psychiatrist excited about success of Sage’s brexanolone but says commercial penetration uncertain), although the commercial opportunity for '217 – in both the broader depression setting and as an oral therapy – is considerably larger. Shares in Sage were up as much 62 percent as a result.

ViewPoints: Sage’s success with ‘547 may be for show, but ‘217 is for dough

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