ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche (OTCQX: RHHBY) announced promising data on its investigational therapies for non-Hodgkin lymphoma (NHL) at the 2021 ASCO Annual Meeting. The bispecific antibodies, mosunetuzumab and glofitamab, demonstrated significant treatment responses, with complete response rates of 71.4% and 54.5% respectively in clinical trials. Roche is targeting a regulatory filing for mosunetuzumab in follicular lymphoma by the end of 2021. Approximately 500,000 new NHL cases are diagnosed annually, highlighting the urgent need for new treatment options amid limited existing therapies.

Roche announced the European Commission's approval of Venclyxto (venetoclax) in combination with hypomethylating agents for adults with newly diagnosed acute myeloid leukaemia (AML) ineligible for intensive chemotherapy. The VIALE-A study showed that Venclyxto plus azacitidine improved overall survival, reducing the risk of death by 34%, with median survival of 14.7 months compared to 9.6 months with azacitidine alone. The approval opens new treatment options for AML patients, significantly enhancing complete response rates and overall survival outcomes.

Roche (RHHBY) announced interim results from the Phase III IMpower010 study, indicating that Tecentriq (atezolizumab) significantly improved disease-free survival (DFS) by 34% for patients with PD-L1-positive resectable early-stage lung cancer compared to best supportive care (BSC). Specifically, median DFS was not reached for Tecentriq, while BSC showed 35.3 months. The overall study cohort saw a 21% reduction in recurrence or death risk. Safety outcomes aligned with known profiles, with 92.7% experiencing adverse events. Full results will be presented at the ASCO Annual Meeting.

Genentech, part of Roche, released interim results from the Phase III IMpower010 study, revealing that Tecentriq® (atezolizumab) significantly reduces the risk of disease recurrence or death in patients with Stage II-IIIA non-small cell lung cancer (NSCLC) expressing PD-L1≥1%. Specifically, disease-free survival (DFS) improved by 34% compared to best supportive care (BSC). Median DFS for Tecentriq is yet to be reached, while BSC stands at 35.3 months. The safety profile remained consistent, with adverse events occurring in 92.7% of Tecentriq patients. Full results will be presented at the 2021 ASCO Annual Meeting.

On May 18, 2021, Roche announced that its cobas® SARS-CoV-2 Test received Emergency Use Authorization (EUA) from the FDA for testing asymptomatic individuals, expanding COVID-19 testing to help reduce virus spread. The test can process pooled samples of up to six individuals, supporting CDC guidance amid findings that asymptomatic individuals account for over half of COVID-19 transmissions. Roche previously enabled 160 million molecular tests in 2020 and continues to innovate in diagnostics, emphasizing public health and the safe reopening of communities.

Roche announced new findings from 19 cancer treatments to be presented at the 2021 ASCO Annual Meeting, scheduled for June 4-8, 2021. The data emphasizes patient-centric approaches, particularly for early-stage non-small cell lung cancer (NSCLC) through Tecentriq, which improves disease-free survival. Roche also highlights tumor-agnostic therapies and data in breast and blood cancer treatments. Significant studies, including ALPHA-T and TAPISTRY, focus on personalized care and decentralized trials. Roche aims to enhance treatment accessibility and equity in oncology.

Roche's Tecentriq (atezolizumab) has received European Commission approval as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) exhibiting high PD-L1 expression. This decision presents an alternative to chemotherapy for eligible patients and represents Tecentriq's fourth indication in metastatic NSCLC and fifth in lung cancer overall within the EU. The approval is based on the Phase III IMpower110 study, demonstrating a significant overall survival improvement of 7.1 months compared to chemotherapy. Roche's development program for Tecentriq continues to expand across various cancer types.

Genentech announced that the FDA Oncologic Drugs Advisory Committee voted 10-1 to maintain the accelerated approval of Tecentriq (atezolizumab) for treating adults with locally advanced or metastatic urothelial carcinoma not eligible for cisplatin chemotherapy and with high PD-L1 expression. This meeting is part of an industry review of accelerated approvals. The FDA has yet to announce a final decision. Tecentriq, approved since 2017, has shown significant efficacy for specific bladder cancer patients, with ongoing studies in various cancers.

On April 28, 2021, Roche (OTCQX: RHHBY) announced that the FDA's Oncologic Drugs Advisory Committee voted 10-1 to maintain the accelerated approval of Tecentriq® for metastatic bladder cancer patients not eligible for cisplatin chemotherapy. This endorsement highlights the significant unmet medical need in this patient population. Roche is committed to advancing Tecentriq's clinical development, having received a similar positive recommendation for triple-negative breast cancer. The FDA's final decision on Tecentriq is pending.