The stakes have changed but Bristol-Myers Squibb's Opdivo/Yervoy bet finally comes in
Bristol-Myers Squibb has top-lined much anticipated data from its two-part CheckMate-227 study in first-line non-squamous non-small-cell lung cancer (NSCLC). Versus chemotherapy, the combination of Opdivo and Yervoy did show an overall survival (OS) benefit, while Opdivo plus chemotherapy did not.
These results are largely unexpected. Bristol-Myers Squibb had initially touted the potential of a Opdivo/Yervoy combination as a means of eliminating chemotherapy use, but PD-(L)1/CTLA4 inhibitor pairings have subsequently showed little promise in lung cancer. As confidence in this approach had waned, CheckMate-227 was modified to include an Opdivo/chemotherapy arm; essentially as a hedge and inspired by impressive data for Merck & Co.'s rival drug Keytruda.
The failure of Opdivo plus chemotherapy to a show an OS survival benefit will therefore fuel speculation that Keytruda is the superior PD-1 inhibitor, though Bristol-Myers Squibb cited a stronger than expected performance for the comparator arm in CheckMate-227.
What commercial opportunity exists for the combination of Opdivo and Yervoy remains unclear until more data are presented, though an OS benefit indicates approvability. Bristol-Myers Squibb said toxicities for this regimen are consistent with prior data for Opdivo and low-dose Yervoy.
Checkmate to Sage in depression showdown?
Sage Therapeutics has confirmed that its closely watched experimental drug SAGE-217 is to be investigated in treatment-resistant depression. The oral drug is already being evaluated for major depressive disorder and post-partum depression (PPD).
The company said Wednesday that the decision was based on a post hoc analysis of Phase III studies in major depressive disorder and PPD, which indicated that SAGE-217 had similar efficacy in patients who were unresponsive to prior antidepressant therapy.
Sage became a commercial-stage company earlier this year when the FDA approved its intravenous drug Zulresso for PPD, although revenue expectations are muted due to its route of administration. Dosed orally, SAGE-217 is the heir apparent to Zulresso in this indication and robust data in PPD were revealed for the former last year.
This week, competitor Marinus Pharmaceuticals revealed that its experimental drug ganaxolone failed to differentiate itself from placebo in patients with PPD after 28 days, appearing to give SAGE-217 a clear run at the oral PPD market.
Marinus has sought to pivot back to an intravenous version of ganaxolone where data have been positive, but investors are not convinced likely due to the smaller commercial opportunity this represents and Zulresso’s head-start. Shares crashed as much as 66% on Tuesday.
GlaxoSmithKline, Merck & Co. present new data supporting diversification plays in HIV
Both GlaxoSmithKline and Merck & Co. are looking to disrupt the HIV market, with new data supporting their respective strategies to do so showcased this week at the International AIDS Society Conference on HIV Science in Mexico City.
GlaxoSmithKline presented more results from the GEMINI 1 and 2 and TANGO studies supporting use of two-drug treatment regimens in treatment-naïve and treatment-switch patients, respectively. It is well established that comprehensive (including real world) data showing sustained virologic response and lack of disease resistance will be critical in supporting use of two-drug treatment regimens.
Merck presented Phase IIb data for islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), which has rapidly gained prominence in recent company presentations as one of its most promising pipeline assets. Based on data presented in Mexico (more here), Merck plans to initiate a Phase III programme evaluating islatravir in combination with doravirine across a diverse set of patient populations.
Merck’s clinical research director Peter Sklar gave FirstWord the low-down on why islatravir could be a game-changer, including its potential use as a preventative HIV therapy.
Allergan, Amgen launch Avastin and Herceptin biosimilars in US
In what could be an important development for the US biosimilars market, partners Allergan and Amgen announced late last week the launch of biosimilar versions of Roche's cancer therapies Avastin and Herceptin.
Adoption of biosimilar products in the US market has so far significantly lagged uptake in the EU for various reasons specific to the mechanics of the US payer environment, though this has not been helped by the aggressive tactics employed by branded companies to use intellectual property as a means of delaying biosimilar launches.
For example, biosimilar versions of AbbVie's Humira and Roche's Rituxan have both been approved by the FDA in the past week, but neither will launch immediately; Samsung Bioepis' Humira biosimilar won't launch for four years.
In contrast, Allergan and Amgen have reportedly chosen to launch their biosimilar Avastin and Herceptin products whilst at risk of further legal action from Roche. The Swiss company hopes to compensate for declining sales caused by biosimilar competition with revenues from newer drugs.
Q2 results - earnings season gathers pace
Roche's first-half results, announced on Thursday, provide further evidence that it is on track to achieve this.
AstraZeneca is also enjoying a period of strong growth, thanks largely to uptake of new oncology franchises.
GlaxoSmithKline is hoping to get back into the oncology game with a number of key data presentations and readouts due later this year. In the meantime, second-quarter results were decent, though performance across key franchises was mixed, noted analysts at Wolfe Research. The onus on successfully convincing physicians on the merits of two-drug HIV regimens and delivering positive data for pipeline assets remains high.
Elsewhere, Biogen faces a similar type of balancing act; growth is being driven by its spinal muscular atrophy (SMA) treatment Spinraza, royalties it receives on Roche's Ocrevus and what appears to be an increasingly strategically important biosimilars collaboration with Samsung Bioepis. Investors, however, want more from the pipeline; particularly with competition in the SMA market set to intensify.
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