NEW YORK – Roche said this week that it will withdraw its immunotherapy atezolizumab (Tecentriq) in combination with nab-paclitaxel as an option for PD-L1-positive, unresectable, locally advanced, or metastatic triple-negative breast cancer. The indication had previously received accelerated approval from the US Food and Drug Administration in March 2019, based on the treatment regimen's impact on progression-free survival in the Phase III IMpassion130. However, continued approval required confirmation of benefit in the IMpassion131 trial, which failed to meet its primary endpoint and show that first-line atezolizumab plus nab-paclitaxel improved progression-free survival in PD-L1-positive, metastatic TNBC patients. Although the FDA's Oncology Drugs Advisory Committee voted 7 to 2 in April in favor of maintaining accelerated approval for this indication of Tecentriq, Roche decided to withdraw it from the market after discussions with the FDA. "Due to the recent changes in the treatment landscape, the FDA no longer considers it appropriate to maintain the accelerated approval," the company said in a statement. "This led to the difficult decision to voluntarily withdraw the US mTNBC indication." Roche added that it will continue to study the PD-L1 inhibitor in metastatic TNBC patients.
Immunocore said this week that the US Food and Drug Administration and the European Medicines Agency (EMA) have accepted its applications for approval of its bispecific fusion protein tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma. The FDA granted tebentafusp priority review and set a target action date of Feb. 23, 2022. The EMA will also review the application under its accelerated assessment program. As part of its regulatory filings, the company submitted data from a Phase III trial that showed a 73 percent one-year overall survival rate among patients on tebentafusp versus 57.5 percent for those on investigator's choice of treatment.
OrigiMed said last week that China's National Medical Products Administration will review its Human NTRK1/2/3 Genomic Alteration Testing Kit under a special review procedure for innovative medical devices. The test is being developed in China as a companion diagnostic for Bayer's TRK inhibitor larotrectinib (Vitrakvi) to identify NTRK gene fusion-positive patients. Bayer submitted larotrectinib for marketing authorization in China in May.
New York City-based Mount Sinai Health System said this week that it has received a $60 million gift from James S. and Merryl Tisch, which it will put toward establishing the Mount Sinai Tisch Cancer Center. The center will include the Tisch Cancer Hospital, the Tisch Cancer Institute at Icahn Mount Sinai, several cancer centers of excellence, and an ambulatory cancer network, and will focus on improving access to breakthrough therapies, diagnostics, and clinical trials. The new center will also help Mount Sinai achieve its mission of providing personalized cancer treatment to patients from all communities and backgrounds.
Caris Life Sciences said this week that the O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham has joined the Caris Precision Oncology Alliance. The alliance is a network of 52 cancer centers that conduct research on predictive and prognostic biomarkers to advance comprehensive cancer profiling and establish standards of care for molecular testing. As part of this network, the O'Neal Comprehensive Cancer Center will gain access to Caris' database and artificial intelligence platform and can participate in biomarker-guided trials sponsored by the pharmaceutical industry.
CellMax Life said this week that its FirstSight colorectal pre-cancer and cancer detection blood test has received breakthrough device designation from the US Food and Drug Administration. The test is based on both circulating cancer cell detection and analysis of circulating tumor DNA, which are algorithmically combined with age and gender to give a readout on whether a patient is at low or high risk of developing colorectal cancer or at high risk for precancer.
The firm said it is currently conducting a multicenter US study to further optimize its test, prior to initiating a pivotal study to support FDA approval.
Aadi Bioscience this week announced the closing of its merger with Aerpio Pharmaceuticals, which it had announced in May. The combined public company began trading on the Nasdaq as Aadi Bioscience under the ticker symbol AADI. Aadi also closed a $155 million private investment in public equity financing round this week. As of the merger close, Aadi has approximately $170 million in cash and cash equivalents and an expected runway into 2024. The company will use the PIPE financing and funds from the deal to advance its lead product candidate, nab-sirolimus (Fyarro), an mTOR inhibitor for the treatment of a rare sarcoma and other tumors harboring TSC1 and TSC2 inactivating alterations.
Sophia Genetics and Brazilian molecular diagnostics firm Dasa said this week that they have expanded an existing partnership to create a decentralized homologous recombination deficiency analytics system. The firms have been working together since 2016.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.