Vicasinabin

Roche is reworking its plans for a quartet of clinical programs spanning different therapeutic areas and stages of development, but it may not be the end of the road for most of the drugs affected. The Swiss drugmaker revealed it was dropping its Phase I solid tumor trial for cibisatamab, as well as Phase II programs for ralmitaront in schizophrenia and vicasinabin in diabetic retinopathy, according to a pipeline document released as part of Thursday’s third-quarter earnings update. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

Pictured: Roche tower in Switzerland/iStock, olli0815 Roche is eliminating four clinical programs amid drooping sales brought about by a sharp decline in demand for COVID-19 products and a strong Swiss franc, the pharma group announced Thursday morning in its third-quarter earnings results. According to a development pipeline document released alongside the quarterly report, Roche will end a Phase I solid tumor trial for its investigational CEA/CD3 bispecific antibody cibisatamab. The company will also stop Phase II trials of its antipsychotic drug candidate ralmitaront in schizophrenia and the developmental cannabinoid receptor agonist vicasinabin in diabetic retinopathy. Roche discontinued the mid-stage study of ralmitaront after it failed a Phase II trial in May 2023, unable to elicit significant improvements on negative symptoms in a preliminary analysis. The vicasinabin and cibisatamab programs were likewise scrapped following underwhelming reviews of their efficacy in their respective studies. However, in a media call Thursday morning, a Roche spokesperson said that these two candidates were still in the very early stages of development and have shown “encouraging early data” warranting further investigation, Fierce Biotech reported. Roche on Thursday also axed a Phase III study of its leukemia therapy Venclexta (venetoclax) in relapsed or refractory multiple myeloma. Last month, the BCL-2 blocker failed to significantly boost progression-free survival when given in combination with dexamethasone, compared to pomalidomide plus dexamethasone. Overall survival was better in patients treated with the Venclexta-based regimen, but it also fell short of statistical significance. Venclexta was first approved in 2016 for the treatment of chronic lymphocytic leukemia with 17p deletion and has since also been authorized for acute myeloid leukemia. Roche is developing and commercializing Venclexta together with AbbVie. The pipeline culling comes as Roche sustains a slight dip in sales. From January to September 2023, the pharma group made over $49 billion, compared with $52.48 billion during the same period in 2022. At constant exchange rates, this corresponds to a small 1% revenue growth—but with the strong appreciation of the Swiss franc represents a 6% decrease. Much of this decline was driven by the “significant drop in demand” of COVID-19 tests, which resulted in an 18% sales decrease at constant exchange rates for Roche’s diagnostics division during the first three quarters of the year. This was more than enough to offset the 9% growth of its pharmaceuticals business. Roche’s best-selling pharma product is its multiple sclerosis therapy Ocrevus (ocrelizumab), which brought in more than $5.3 billion in the first nine months of 2023. This was followed by the hemophilia A treatment Hemlibra (emicizumab), breast cancer antibody Perjeta (pertuzumab) and blockbuster cancer immunotherapy Tecentriq (atezolizumab). Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.