Roche Q3 Report: Key R&D Breakthroughs in Oncology and Neuroscience

Today, Roche announced its operational results for the third quarter of this year. During the third quarter, Roche secured approvals for several innovative therapies: including the “tumor-agnostic” therapy Rozlytrek, which received FDA approval for the treatment of non-small cell lung cancer (NSCLC) with ROS1 gene mutations and solid tumors with NTRK fusions. In the European Union, the PD-L1 inhibitor Tecentriq gained approval for expanded indications in three areas, to be used in combination with chemotherapy for the treatment of patients with specific types of triple-negative breast cancer, non-small cell lung cancer, and small cell lung cancer. During the conference call, Roche also reported on the company’s latest research and development progress. Today, the WuXi AppTec content team will share with readers the latest R&D breakthroughs highlighted by Roche executives.

Oncology: Tecentriq Achieves Repeated Breakthroughs

In oncology, Roche’s blockbuster PD-L1 inhibitor, Tecentriq, represents one of the company’s key R&D priorities. According to Roche executives, six regulatory submissions for Tecentriq are planned over the next two years to further expand its indications. These include first-line treatment of metastatic urothelial carcinoma, first-line treatment of hepatocellular carcinoma, first-line treatment of BRAF-mutant melanoma, and neoadjuvant therapy for triple-negative breast cancer, among others. During the conference call, Roche highlighted the latest progress of Tecentriq in the treatment of hepatocellular carcinoma and lung cancer.

▲Recent R&D Developments of Tecentriq (Image source: reference materials)^[1]）

Roche has announced the results of using Tecentriq in combination with the VEGF inhibitor Avastin as a first-line treatment for hepatocellular carcinoma (HCC) at this year’s ESMO Congress. During the conference call, Bill Anderson, CEO of Roche Pharmaceuticals, emphasized that this combination can provide deep and durable responses for patients with hepatocellular carcinoma. The combination therapy achieved an objective response rate of 36%, and among those who responded, 76% remained in response at a median follow-up time of 12.4 months.

Moreover, this trial demonstrated a synergistic effect between the VEGF inhibitor Avastin and Tecentriq. The combination of Avastin and Tecentriq reduced the risk of disease progression or death by 45% compared with Tecentriq monotherapy. The Phase III clinical results for the Tecentriq and Avastin combination therapy in hepatocellular carcinoma are expected to be announced in the fourth quarter of this year.

▲Efficacy data of Tecentriq + Avastin in patients with hepatocellular carcinoma (Image source: References)^[1]）

In the treatment of non-small cell lung cancer (NSCLC), Roche emphasized that Tecentriq, as a monotherapy for first-line treatment of NSCLC patients with high PD-L1 expression, can significantly improve overall survival. Compared with platinum-based chemotherapy, Tecentriq reduces the risk of death in this patient population by 41%. These positive results not only position Tecentriq to become the second PD-1/PD-L1 inhibitor approved as a first-line monotherapy for NSCLC, following Keytruda, but also lay a solid foundation for further development of combination therapies. Roche also stated that its pipeline in NSCLC covers all patient types and stages of disease progression, including both PD-L1-positive and PD-L1-negative patients, as well as early-stage patients receiving neoadjuvant/adjuvant therapy.

▲Overall Survival Data of Tecentriq in NSCLC Patients and Roche’s R&D Layout for Lung Cancer Treatment (Image Source: Reference Materials)^[1]）

Neuroscience: Risdiplam and Satralizumab to Submit New Drug Applications This Year

In the field of neuroscience, Roche’s oral SMN2 gene splicing modifier, risdiplam, for the treatment of spinal muscular atrophy (SMA), has consistently demonstrated superior efficacy in clinical trials. This medication sustains increased expression of the SMN protein in both the central and peripheral nervous systems, exhibiting potential “best-in-class” therapeutic characteristics.

In the Phase 3 FIREFISH clinical trial, patients with the most severe Type 1 spinal muscular atrophy (SMA) received treatment with varying doses of risdiplam. Most of these patients initiated treatment between 5 and 8 months of age, by which time they had already developed multiple motor function impairments. Among these severely affected patients, risdiplam demonstrated favorable efficacy; the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) motor function scores of patients receiving high-dose risdiplam continued to improve throughout the course of treatment. After 16 months of therapy, 82% of patients achieved a CHOP-INTEND score greater than 40. Without treatment, such patients would almost never reach this level.

Moreover, no patients required permanent respiratory support. Clinical trials for the treatment of patients with milder Type 2/3 SMA are expected to release results in the fourth quarter of this year.

▲ Motor function scores in patients with type 1 SMA at 16 months of risdiplam treatment (Image source: reference materials)^[1]）

The company’s IL-6 monoclonal antibody, satralizumab, is an innovative therapy with the potential to serve as a first-line treatment for neuromyelitis optica spectrum disorder (NMOSD). In NMOSD patients, immune-mediated attacks on the myelin sheath that protects nerves lead to symptoms such as vision loss and disability, with 50% of patients becoming blind within five years. As each disease relapse exacerbates disability, preventing relapses is key to slowing disability progression.

Satralizumab has demonstrated robust efficacy both as monotherapy and as an add-on therapy to non-immunosuppressive agents. As monotherapy, satralizumab reduced the risk of disease relapse by 55% in the intention-to-treat population. Among patients positive for aquaporin-4 (AQP4) autoantibodies—autoantibodies targeting the AQP4 protein that are a major cause of neuromyelitis optica spectrum disorder (NMOSD)—satralizumab reduced the risk of relapse by 74%. In this subgroup, up to 77% of patients remained free of any disease relapse after two years of treatment.

▲Efficacy Data of Satralizumab Monotherapy (Image Source: Reference Materials)^[1]）

Roche, renowned for developing breakthrough therapies, has secured 28 FDA Breakthrough Therapy Designations this year, with 75% of its R&D projects ultimately gaining FDA approval. In the fourth quarter of this year, the company will also announce further advancements in hematology, oncology, and immunology. Let us look forward to more positive R&D updates from Roche, bringing innovative products to patients sooner and benefiting their health.

▲ Roche’s R&D projects that have received FDA Breakthrough Therapy Designation (Image source: reference materials)^[1]）

References:

[1] Roche YTD September 2019 sales. Retrieved October 16, 2019, from https://www.roche.com/dam/jcr:856bb040-90a8-48ec-bbbc-e014f02541f1/en/irp191016-a.pdf

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