With deals in tow, Roche ends 2019 with five discarded programs
With sales coming in just shy of Wall Street estimates and profit that just beat expectations, Roche capped off 2019 on a high having finally consummated its arduous acquisition of Spark Therapeutics. That buyout was marred with no less than 10 delays due to regulatory concerns about anticompetitive dealmaking. As is the tradition, the company also culled a number of experimental drugs across its pipeline.
The first early-stage program on the chopping block is a combination of its cancer therapy Venclexta, which is partnered with AbbVie and was first approved in 2016 for CLL. Last year, the companies were forced to press pause on a range of multiple myeloma trials testing the drug, after higher death rates on the Venclexta arm forced the FDA to impose a partial hold on patient recruitment. A few months later, one trial was allowed to resume, but Venclexta remains under a cloud. On Thursday, the Swiss drugmaker cut a Phase I study testing the drug in combination with the TKI Cotellic and checkpoint inhibitor Tecentriq in patients with relapsed or refractory multiple myeloma.
Another early-stage cut is the Chugai-partnered bispecific antibody — ERY974 — that was under evaluation for use in solid tumors.
In addition, a Phase I program for chronic hepatitis B infection — RG6004 — was also discarded. The decision may be related to Roche’s $200 million upfront deal with Dicerna, which is working on an RNAi approach in a bid to cure the disease.
Last year, Roche’s Tecentriq — in combination with chemotherapy — managed to secure approval for patients with metastatic PD-L1 positive triple-negative breast cancer (TNBC), a notoriously hard-to-treat form of the disease. Another TNBC drug in Roche’s arsenal is ipatasertib (RG7440), a drug the company got from Array to address T cell-mediated immunotherapy resistance and is currently in a late-stage monotherapy study. Last April, Roche posted some encouraging early results from a trial testing ipatasertib+Tecentriq+paclitaxel — and have since moved into a Phase III TNBC trial. However, Roche has now killed a program testing the drug’s impact in combination with Tecentriq and Taxane in TNBC.
Speaking of Tecentriq — Roche’s star PD-L1 therapy got a rare approval in 2019 for an indication that Merck’s leading checkpoint inhibitor Keytruda was not able to make an overall survival impact on — extensive-stage small cell lung cancer. SCLC patients account for roughly 10% to 15% of all lung cancer cases. The bulk of diagnoses, however, come from non-small cell lung cancer (NSCLC), making it the most lucrative market within oncology. A section of this population — non-squamous NSCLC — was initially within the grasp of Keytruda, but Tecentriq combos have also secured approval for certain frontline cases. On Thursday however, one Tecentriq combo including two chemotherapies was given the boot in a late-stage trial testing patients with non-squamous NSCLC.
And finally, there’s Roche’s experimental DMD therapy. Back in November, Roche publicly declared its decision to abandon the drug —RG6206 — that was designed to inhibit myostatin, after it failed a futility analysis. Back in 2017, the drug was licensed for $170 million upfront from Bristol-Myers Squibb. The program marked yet another failure in a field littered with flopped myostatin drugs — including compounds from Novartis and Pfizer.
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