NEW YORK – Roche announced this week that its Elecsys Growth Differentiation Factor-15 (GDF-15) test received breakthrough device designation from the US Food and Drug Administration as a companion diagnostic in cancer treatment. The quantitative serologic immunoassay measures GDF-15 in patients with solid tumors for treatment with Pfizer’s investigational drug PF-069446860. Elevated GDF-15 levels can indicate cachexia in cancer patients, a complication of cancer associated with involuntary weight loss, muscle atrophy, and reduced appetite that can also lead to death. The assay is intended for use on Roche’s Cobas e platform.
Novartis said this week that the US Food and Drug Administration granted breakthrough therapy designation for the firm's investigational STAMP inhibitor asciminib as a treatment for Philadelphia chromosome-positive chronic myeloid leukemia. Specifically, the designation is for patients with chronic-phase disease who have been treated with at least two tyrosine kinase inhibitors. The FDA also granted breakthrough therapy designation to asciminib for Philadelphia chromosome-positive CML harboring T315I mutations. The agency based the designations on data from the Phase III ASCEMBL trial, as well as a separate Phase I trial that included patients with T315I mutations.
Basilea Pharmaceutica this week announced topline results from the Phase II FIDES-01 study cohort evaluating derazantinib in patients with bile duct cancer characterized by FGFR2 gene fusions. Among 103 previously treated patients with inoperable or advanced intrahepatic cholangiocarcinoma, derazantinib had an objective response rate of 20.4 percent and a median progression-free survival of 6.6 months. The disease control rate, defined as the proportion of patients with a partial response or stable disease, was 72.8 percent. The Swiss firm said the results from this cohort of the trial were not yet mature, with 12 patients continuing treatment. Enrollment for cohort 2 of the study, which includes bile duct cancer patients with FGFR2 gene mutations or amplifications, is still ongoing.
A number of studies in the FIDES clinical trial program, evaluating derazantinib alone and in combination with other drugs, will read out in 2021 and 2022. The company also said this week that in the FIDES-02 study evaluating derazantinib monotherapy and derazantinib with the checkpoint inhibitor atezolizumab (Genentech's Tecentriq) in advanced urothelial cancer patients harboring FGFR genetic aberrations, the combination was well tolerated and none of the patients experienced dose-limiting toxicities. Basilea noted that several patients are still receiving the derazantinib-atezolizumab combo and highlighted that one patient with bile duct cancer characterized by an FGFR2 fusion has had a partial response and is continuing to respond after being on the study for nine months. Based on the safety profile of the combination seen to date, Basilea will amend the FIDES-02 study protocol and explore whether higher doses of derazantinib may further improve patient outcomes.
Revolution Medicines said this week that it has closed its upsized public offering of 6,666,666 shares of common stock at $45 per share, raising gross proceeds of $300 million. The total shares sold include 869,565 shares that the company offered as an additional option to underwriters at the public offering price, which they exercised in full. JP Morgan, Cowen, SVB Leerink, and Guggenheim Securities were the joint book-running managers for the offering.
Genetron Health said this week that its early liver cancer screening research results were mentioned in new guidelines issued by the Chinese Anti-Cancer Association for liver cancer prevention and treatment. The new recommendations specifically cite a study published by Genetron Health and China's National Cancer Center in the Proceedings of the National Academy of Sciences, stating that methylation-based circulating tumor DNA tests like Genetron’s can help improve screening when added to traditional protein biomarkers.
Bionano Genomics said this week that the Laboratory Medicine Program (LMP) of the University Health Network in Toronto, the largest hospital diagnostic laboratory in Canada, plans to test its Saphyr optical genome mapping platform for diagnosing chromosomal abnormalities in cancer. Specifically, the network's Cancer Cytogenetics Laboratory will evaluate the Saphyr technology for detecting chromosomal changes as a possible alternative, with better resolution and less labor, to karyotyping and fluorescence in situ hybridization (FISH).
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.