Etrolizumab

Smith Collection Gado_Getty Images In Roche’s 2021 annual report, the company detailed that group sales rose 9%, pharmaceutical sales up 3%, and diagnostics up a whopping 29%. Smith Collection_Gado_Getty Images In Roche ’s 2021 annual report , the company detailed that group sales rose 9%, pharmaceutical sales were up 3%, and diagnostics up a whopping 29%. The company noted that it had halted a Phase III development program for etrolizumab for Crohn’s disease, as well as a few others in the middle of all financial news. Roche’s big approvals in the fourth quarter included Susvimo and Vabysmo for age-related blindness in the U.S.; in Europe, Gavreto for a specific form of advanced lung cancer, Actemra/RoActemra for severe COVID-19 and Ronapreve for non-hospitalized COVID-19 patients and prophylaxis. In the diagnostics arena, in the fourth quarter, the company noted approvals for its cobas 5800 molecular laboratory system, Avenio Edge sequencing sample preparation system, cobas pulse and cobas infinity edge digital ecosystem for clinical decision support and additional SARS-CoV-2 tests. The company expects sales for 2022 to be stable or to grow in the low-single digits. And in what is a hopeful sign for the world but not necessarily for Roche’s bottom line, the company said it expects sales of COVID-19-related drugs and diagnostics to fall by approximately CHF 2 billion ($2.17 billion) with sales drops for biosimilars of around CHF 2.5 billion ($2.7 billion). Otherwise, group sales are projected to grow in the high-single digit range. “We achieved good results in 2021,” stated Severin Schwan, Roche’s Chief Executive Officer. “The demand for our new medicines and diagnostics remains very high. I am particularly pleased with the progress of our product pipeline across several areas, including oncology, vision loss and neurological diseases. Based on our strong product portfolio in both divisions and the promising product pipeline, we are well-positioned for future growth.” In August 2020, Roche announced mixed topline results for its Phase III program of etrolizumab in patients with moderately to severely active ulcerative colitis, an inflammatory bowel disease similar to Crohn’s disease. The drug hit the primary endpoint of inducing remission compared to placebo in two of three studies, but the drug missed the primary endpoint versus placebo as maintenance therapy in ulcerative colitis. At the time, Dr. Levi Garraway, Roche’s chief medical officer and head of global product development, said, “We are disappointed with these results, because we know that people with ulcerative colitis need new treatment options. We are fully analyzing these data to learn more about how we might address the needs of people with this devastating disease. These studies were part of the largest clinical trial program ever undertaken in inflammatory bowel diseases, and we thank all the patients, investigators and healthcare professionals for their participations.” The studies in Crohn’s disease with and without previous anti-TNF treatment was continuing in the Phase III BERGAMOT trial and open-label extension and safety monitoring study (JUNIPER). Etrolizumab is a dual anti-integrin designed to selectively inhibit alpha4beta7 and alphaEbeta7 to control the trafficking of immune cells into the gut and their inflammatory effects on the lining of the gut. Whatever data on these studies Roche observed, it wasn’t strong enough to throw more time and money at. Roche also announced another Phase III program it was axing, RG6422, an oral COVID-19 antiviral it was developing with Atea Pharmaceuticals. In Phase II, Roche was halting SPK-7001, a choroideremia gene therapy it was developing with Spark Therapeutics, and RG7992 for nonalcoholic steatohepatitis (NASH), and RG7835 for autoimmune disorders.

Jonathan Weiss/Shutterstock Roche is closing out its fourth-quarter with some house cleaning. The Swiss pharma giant announced in its earnings report that it was terminating studies of several mid- and late-stage assets, including two late-stage breast cancer programs. Jonathan Weiss / Shutterstock Roche is closing out its fourth-quarter with some house cleaning. The Swiss pharma giant announced in its earnings report that it was terminating studies of several mid- and late-stage assets, including two late-stage breast cancer programs. In its fourth-quarter presentation, Roche noted several programs that have been terminated after earlier clinical trial failures in 2020. Roche included a checklist for ongoing programs and the ones that have been terminated included a large, red X. One of the studies terminated is the Phase III IMagyn050 trial assessing a combination of two previously approved cancer drugs. The study was seeking to determine if adding Tecentriq (atezolizumab) to a combination of Avastin (bevacizumab), paclitaxel and carboplatin would make a difference in the treatment of women with newly diagnosed advanced-stage ovarian cancer. It did not. The addition of Tecentriq did not improve progression-free survival to the first-line combination therapy. Another program terminated is the Phase III IPATunity130 study. That trial was assessing ipatasertib, an Akt inhibitor, and chemotherapy for the treatment of patients with PIK3CA/AKT1/PTEN-altered hormone receptor-positive, HER2-negative advanced breast cancer. The trial failed to meet its endpoints of both progression-free survival and objective response rate. AKT1/2/3, which ipatasertib inhibits, is the central node of the PI3K/AKT pathway, which plays a critical role in HR-positive, HER2-negative breast cancer. Although ipatasertib missed the mark in the breast cancer study, Roche is still investigating its use in other cancers. Last year, the asset hit the mark in the Phase III IPATential150 study in patients with metastatic castration-resistant prostate cancer whose tumors had PTEN loss. Ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, the company said at the time. The other Phase III program culled by Roche is a combination of idasanutlin, an MDM2 antagonist, and chemotherapy for the treatment of acute myeloid leukemia. The combination failed to reach endpoints of improving survival in the late-stage MIRROS program. Roche had hoped to determine if the addition of idasanutlin to chemotherapy would prove superior to chemotherapy alone. The addition of the MDM2 antagonist did not prolong life in those patients. Although idasanutlin failed in the MIRROS trial, Roche and Genentech are investigating it along with Venclexta in patients with relapsed or refractory AML who are not eligible for chemotherapy. It wasn’t just late-stage programs that saw the proverbial axe. Roche also terminated two mid-stage programs in ulcerative colitis and autism spectrum disorder. Roche subsidiary Genentech reported etrolizumab demonstrated a mixed bag in a Phase III ulcerative colitis test. While the drug hit its endpoint of inducing remission versus placebo, it failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitis. The autism study that Roche terminated involved an asset that received Breakthrough Therapy designation in 2018. Last year, Roche announced it was terminating the trial assessing balovaptan, a vasopressin 1a (V1a) receptor antagonist. Roche stopped the Phase II study of balovaptan early last year following a futility assessment. In its fourth-quarter report , Roche said sales in its Pharmaceuticals Division decreased 2% to CHF 44.5 billion, mainly due to stronger than expected biosimilars competition and the COVID-19 pandemic. Sales in the U.S. slipped 6%. Roche said biosimilars for blue-chip assets MabThera/Rituxan, Herceptin and Avastin were particularly impacted by biosimilars. Tecentriq sales increased mainly due to growth in the new indications, including certain forms of lung, breast and liver cancer, the company said.