NEW YORK – Cancer diagnostics firm Precipio said this week that it has signed a distribution deal with an undisclosed partner for its HemeScreen test for detecting hematologic malignancies. The new distributor is focused on a healthcare segment with a $100 million potential market opportunity, the New Haven, Connecticut-based firm said. In July, Precipio announced a distribution deal with Thermo Fisher Scientific's Fisher Healthcare for HemeScreen.
AnHeart Therapeutics and NewG Lab Therapeutics said this week that Korea's Ministry of Food and Drug Safety granted orphan drug designation to their next-generation tyrosine kinase inhibitor taletrectinib for patients with advanced or metastatic ROS1-positive non-small cell lung cancer. The companies are evaluating the drug in a global Phase II trial (TRUST-II) at multiple sites in Korea in patients who are ROS1 TKI naïve or were previously treated with Pfizer's Xalkori (crizotinib). Taletrectinib was granted breakthrough therapy designation by the US Food and Drug Administration in August 2022.
Strata Oncology this week announced that it has expanded a collaboration with Pfizer for its Strata PATH trial, a prospective pan-tumor study looking into the efficacy and safety of FDA-approved cancer therapeutics for new, biomarker-defined patient populations. As part of the expanded partnership, Pfizer will provide its drugs Braftovi (encorafenib), Mektovi (binimetinib), and Lorbrena (lorlatinib) for six new cohorts enrolling patients with early-stage lung cancer, colorectal cancer, melanoma, and other cancers that have remaining micrometastatic disease following initial treatment. Pfizer has already been supplying Braftovi, Mektovi, Lorbrena, Talzenna (talazoparib), and Inlyta (axitinib) for PATH trial cohorts enrolling patients with late-stage cancers. Many of the patients enrolled in the new cohort with micrometastatic disease will be tested through Strata's Sentinel trial, a 100,000-patient study of Strata's circulating tumor DNA minimal residual disease test.
Delfi Diagnostics will serve as the liquid biopsy partner for the European, multinational lung cancer screening trial 4-IN-THE-LUNG-RUN, or 4ITLR, the company said this week. In the trial, investigators are studying how often at-risk individuals should be screened if their initial CT scan is negative. Under the collaboration, Delfi will analyze the first 9,000 subjects enrolled in the trial in the Netherlands and France, aiming to assess whether its test can identify individuals who are most likely to benefit from more frequent CT scans. Financial terms of the collaboration were not disclosed.
The Australian Therapeutic Goods Administration this week provisionally approved Incyte's Pemazyre (pemigatinib) for treatment of patients with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement which has progressed following at least one line of systemic therapy. The decision is based on the FIGHT-202 Phase II trial involving 108 patients, which showed an objective response rate of 37 percent and a disease control rate of 82.2 percent. The Australian approval follows approvals in the US, Europe, the UK, Canada, and Japan.
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.