FDA accepted the supplemental Biologics Application for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage 2A to 3B non-small cell lung cancer. FDA assigned a Prescription Drug User Fee Act goal date of Oct. 8.
The current standard of care for identifying targetable mutations in cancer treatment is to conduct molecular profiles on tumor tissue samples, but a study published in JAMA Network Open indicates that adding liquid biopsy testing for circulating tumor DNA mutations increases targetable mutation detection rates.
A study led by researchers from the UCLA Health Jonsson Comprehensive Cancer Center showed that using high doses of radiation while integrating an ablative radiotherapy technique called stereotactic ablative radiotherapy concurrently with chemotherapy is safe and effective in treating people with locally advanced non-small cell lung cancer that is not suitable for surgery.
Data published in The Journal for ImmunoTherapy of Cancer show ClearNote Health’s epigenomic platform may provide a novel tissue-free, liquid biopsy-based approach for prediction and monitoring of immunotherapy response for non-small cell lung cancer patients.
Merck and Moderna Inc. have initiated the phase III randomized INTerpath-002 trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Keytruda as adjuvant treatment in patients with completely resected (R0) Stage II, IIIA or IIIB (with nodal involvement [N2]) non-small cell lung cancer.
Infinimmune and Grid Therapeutics formed a partnership to collaborate on identifying new antibody drug candidates for non-small cell lung cancer.
AnHeart Therapeutics and Foundation Medicine Inc. have entered a strategic collaboration for the development and regulatory approval of Foundation Medicine’s tissue- and liquid-based comprehensive genomic profiling tests, FoundationOne CDx and FoundationOne Liquid CDx, as companion diagnostics for AnHeart’s investigational next-generation ROS1 inhibitor, taletrectinib, in the United States.
AnHeart Therapeutics has entered into an exclusive license agreement with Nippon Kayaku Co., Ltd to market and distribute AnHeart’s lead investigational therapy, taletrectinib, in Japan.
In the phase III ALINA study, Alecensa (alectinib) reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in people with completely resected stage 1B (tumor ≥4 cm) to 3A (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.
Results from the phase II TRUST-II trial demonstrate that taletrectinib, an investigational next-generation ROS1 inhibitor, shrank tumors (confirmed objective response rate, cORR, as assessed by an independent review committee, IRC) in 92% of patients with advanced ROS1-positive non-small cell lung cancer who had not previously been treated with a ROS1 tyrosine kinase inhibitor.
