NEW YORK – Gilead Sciences said this week that Health Canada has approved its antibody-drug conjugate sacituzumab govitecan-hziy (Trodelvy) for previously treated, advanced triple-negative breast cancer patients. The approval in Canada, based on the results of the Phase III ASCENT trial, follow approvals for the same indication in the US, Australia, Switzerland, and the UK, among other countries. Health Canada approved the drug under the Project Orbis initiative, through which the US Food and Drug Administration's Oncology Center of Excellence works with international regulatory authorities to expedite access to high-impact oncology drugs.
Iovance Biotherapeutics this week officially opened its Iovance Cell Therapy Center (iCTC), a Philadelphia-based facility devoted to manufacturing the firm's autologous tumor infiltrating lymphocyte (TIL) therapies. According to Iovance, the iCTC, located at the Philadelphia Navy Yard, is the first centralized, scalable, manufacturing facility dedicated to producing TIL therapies to treat solid tumors. The firm expects that the 136,000 square foot iCTC will meet the potential demand of thousands of patients per year. As of now, Iovance is using the facility to supply its clinical trials but plans to use it to meet commercial manufacturing demand once its TIL therapies have secured regulatory approval.
Eli Lilly said this week that the US Food and Drug Administration has expanded the label for its EGFR-targeting agent cetuximab (Erbitux), adding the indication of cetuximab combined with Pfizer's encorafenib (Braftovi) for metastatic colorectal cancer patients whose tumors harbor BRAF V600E mutations. In April 2020, the agency approved the drug combination for this same indication based on the results of the Phase III BEACON CRC trial. Now, the indication is incorporated into cetuximab's label as well as encorafenib's.
Darmstadt, Germany-based Merck KGaA said this week it has decided with GlaxoSmithKline to terminate their agreement to develop the investigational bifunctional immunotherapy bintrafusp alfa, effective Sept. 30. The firms decided to do so following lackluster results in the Phase III [email protected] Lung 037 trial, in which they were exploring the activity of bintrafusp alfa in stage IV non-small lung cancer patients with high PD-L1 expression. Based on the recommendation of an independent data monitoring committee Merck KGaA discontinued the study because it was unlikely to meet its coprimary endpoints of progression-free and overall survival. The data generated during the period of the companies' agreement did not trigger milestone payments from GSK to Merck and no future milestone obligations remain. Merck said it will use advanced analytics to look further into the data on bintrafusp alfa, which is designed to inhibit TGF-beta and PD-L1.
Aspira Women's Health said this week that it has reached agreements with four organizations for the transfer of its technology. The Austin, Texas-based firm did not disclose the organizations' names but said two are women's healthcare groups with more than 750 providers caring for more than 950,000 patients each year, and two are independent laboratories providing services across five states. The agreements allow these entities to perform genetic testing for hereditary cancer and carrier screening, or OVA1plus testing in-house using the Aspira Synergy platform, which enables point-of-care testing. Further terms of the deals were not disclosed. Aspira launched its technology transfer program, Aspira Synergy, during Q2 2021.
Liquid biopsy firm Nonagen Bioscience said this week the US Food and Drug Administration has granted breakthrough device designation to its Oncuria noninvasive bladder cancer test for predicting therapy response. The multiplex immunoassay measures 10 protein biomarkers in a single voided urine sample using a weighted algorithm, which can aid in predicting how patients respond to bacillus Calmette-Guerin. The attenuated tuberculosis vaccine acts as a non-specific immune system stimulant and has shown success in eradicating residual bladder cancer, but more than half of the patients who receive the treatment fail to respond to it.
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.