NuCana announces initial data from Phase 1b/2 modular study of NUC-3373

NuCana (NCNA) announced that initial data from the ongoing Phase 1b/2 modular study investigating NUC-3373 in combination with the PD-1 inhibitor pembrolizumab for patients with advanced solid tumors and in combination with docetaxel for patients with lung cancer have been published in MedRxiv, the preprint server for Health Sciences. Module 1 included 12 patients with a variety of solid tumors who had exhausted all other treatment options. The majority of patients had received prior PD-(L)1 based therapy. Encouraging signals of anti-cancer activity were observed with confirmed Partial Responses in 2 patients and Stable Disease in a further four patients, resulting in an objective response rate of 22% and a disease control rate of 67% in the efficacy evaluable population. The combination of NUC-3373 plus pembrolizumab was generally well tolerated. Module 1 Selected Case Studies: NUC-3373 plus pembrolizumab in patients with advanced solid tumors: 72-year-old patient with urothelial bladder cancer who had previously received gemcitabine plus cisplatin followed by the PD-L1 inhibitor atezolizumab. Following treatment with NUC-3373 plus pembrolizumab, the patient achieved 100% reduction in the target lesion and remains on treatment for over 10 months. 75-year-old patient with BRAF mutant metastatic cutaneous melanoma who had previously received pembrolizumab followed by dabrafenib plus trametinib. Following treatment with NUC-3373 plus pembrolizumab, this patient achieved a confirmed Partial Response with an 81% reduction in the target lesion and remains on treatment for over 12 months. Module 2 included 4 patients with non-small cell lung cancer or pleural mesothelioma who had disease progression on, or were unable to tolerate, prior chemotherapy-containing regimens. Docetaxel is the current standard of care for NSCLC patients without targetable alterations who progress on PD-(L)1 inhibitor-based therapy, however, it is associated with modest clinical benefit and substantial toxicity. Following treatment of the first 4 patients in this module, enrollment was put on hold due to toxicity challenges with docetaxel. Despite this, 2 patients achieved prolonged Stable Disease. Protocol modifications to include the use of a different taxane in this combination are currently being considered. Module 2 Selected Case Studies: NUC-3373 plus docetaxel in patients with lung cancer: 60-year-old patient with pleural mesothelioma who had previously received carboplatin plus pemetrexed, the PD-1 inhibitor nivolumab, and carboplatin plus pemetrexed. Following treatment with NUC-3373 plus docetaxel, the patient achieved Stable Disease for more than 13 months. 77-year-old patient with squamous NSCLC who had previously received carboplatin plus paclitaxel plus pembrolizumab followed by maintenance pembrolizumab. Following treatment with NUC-3373 plus docetaxel, the patient achieved Stable Disease for 7 months.