Skip to main content
Premium Trial:

Request an Annual Quote

In Brief This Week: AstraZeneca, CytoDyn, BerGenBio, Bayer, Dana-Farber Cancer Institute, Kronos Bio

NEW YORK – AstraZeneca this week said the Scottish Medicines Consortium, the cost-effectiveness appraisal body within the National Health Service Scotland, has recommended adjuvant treatment with osimertinib (Tagrisso) for early-stage EGFR-mutated non-small cell lung cancer patients after surgical tumor resection. According to a statement from the drugmaker, SMC is the first organization in the world to complete a cost-effectiveness appraisal of adjuvant osimertinib after the Medicines and Healthcare Products Regulatory Agency in May extended the drug's marketing license in Great Britain based on results from the Phase III ADAURA trial. Patients must have stage IB to IIIA disease and have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in their tumors to receive the drug for a maximum of three years. AstraZeneca estimates that around 25 early-stage NSCLC patients in Scotland will be eligible for adjuvant osimertinib yearly. The drug has been available for this indication in the US since last year.

CytoDyn this week submitted an application to the US Food and Drug Administration for breakthrough therapy designation for leronlimab as a potential treatment for metastatic triple-negative breast cancer. Early data from a Phase IB/II trial of leronlimab, a CCR5 antagonist, showed that TNBC patients treated with the drug and chemotherapy had a median overall survival of more than a year, and 25 percent of patients achieved a partial response from the treatment. CytoDyn has already received fast track designation from the FDA for leronlimab for this indication.

BerGenBio said this week that the US Food and Drug Administration has granted fast track designation for its AXL inhibitor bemcentinib combined with a PD-1 checkpoint inhibitor for advanced non-small cell lung cancer patients harboring STK11 alterations but no other actionable mutations. According to the Norway-based company, preclinical studies in NSCLC suggest that tumors harboring STK11 mutations may be more sensitive to PD-1 blockade when treated also with bemcentinib, since systemically inhibiting AXL with bemcentinib could expand tumor-associated T cells and restore responses to anti-PD-1 therapy. 

Bayer and the nonprofit Life Raft Group this week announced a research collaboration to expand access to comprehensive genomic testing for gastrointestinal stromal tumor patients. The program will offer comprehensive genomic testing for free to GIST patients who have not previously received genetic testing and who agree to be part of the Life Raft Group GIST Patient Registry. The partners hope to expand biomarker screening for GIST patients beyond testing for single genes, like c-KIT, PDGFRA, and BRAF, and use comprehensive genomic testing to identify more GIST patients who harbor NTRK fusions, for which there are marketed treatments.

SEngine Precision Medicine and Dana-Farber Cancer Institute this week announced a collaboration to make SEngine's PARIS diagnostic test available to adult and pediatric patients with primary or metastatic solid tumor central nervous system cancers. Dana-Farber's Center for Patient Derived Models will develop tumor models from patients' biopsy samples, which will be treated with various drugs at SEngine's lab. The PARIS test assesses up to 44 drugs and therapy combinations in each patient's tumor and ranks the therapies in a report to inform treatment selection.

Under an expanded partnership, Kronos Bio will have broad access to Tempus' real-world data and proprietary precision oncology tools and materials, the companies said this week. San Mateo, California-headquartered Kronos will use Tempus' tools, such as its repository of molecularly profiled organoids, to generate preclinical hypotheses, inform clinical trial designs, and advance its portfolio of cancer drugs. The expanded partnership will leverage the two firms' computational biology capabilities as well as Kronos' transcriptional regulation expertise and Tempus' next-generation sequencing capabilities. In the deal, Kronos can also join Tempus' TIME Trial Network, within which Tempus helps partners identify and enroll patients into trials and activate study sites. The latest arrangement builds on a partnership the two firms announced in February, within which Chicago-based Tempus is molecularly profiling patients' tumor samples within Kronos' Phase I/II trial of the CDK9 inhibitor KB-0742.

PureTech Health said this week that its pancreatic cancer agent LYT-200 has received orphan drug designation from the US Food and Drug Administration. The Boston-based firm is currently evaluating the anti-galectin-9 monoclonal antibody in an adaptive Phase I/II clinical trial and believes that galectin-9 could be both a therapeutic target and cancer biomarker for a range of cancer types, including pancreatic, colorectal, and bile duct cancer. PureTech expects to report results from the dose-escalation portion of an ongoing Phase I trial during the first half of 2022.

Caris Life Sciences said this week that the Georgia Cancer Center at Augusta University has joined its Precision Oncology Alliance, a collaborative network of 55 leading cancer centers and academic institutions seeking to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology.

Georgia Cancer Center leads the state’s only minority-based research program through the National Cancer Institute’s Community Oncology Research Program. The cancer center is also on its way to achieving NCI designation, which would give it national recognition as a leader in cancer research including clinical trials. By joining Caris' POA, the center gains early access to the firm's extensive database and Molecular Intelligence platform as well as to a network of precision medicine clinical trials and collaborative opportunities with other alliance members.

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.