NuCana plc, a biopharmaceutical company focused on developing innovative cancer therapies, delivered exciting news at the ESMO Congress on Saturday. Their Phase 2 NuTide:701 study, investigating the combination of NUC-7738 and Merck & Co Inc.’s Keytruda (pembrolizumab) for metastatic melanoma, revealed encouraging results.
The study focused on patients with metastatic melanoma who had previously failed or relapsed on PD-1 inhibitor therapy. This group of patients typically has a poor prognosis with current standard treatments, with a median progression-free survival of just 2-3 months.
The NuTide:701 study enrolled 12 patients, most of whom had received at least two prior lines of PD-1 inhibitor therapy. The results were impressive: 75% of the patients achieved disease control, including two who achieved partial responses. One patient, who had progressed on their latest treatment of ipilimumab plus nivolumab within two months, experienced a remarkable 55% reduction in tumor volume. Furthermore, seven out of the 12 patients achieved a progression-free survival of over five months.
These results are highly encouraging considering the challenging nature of the patient population. Hugh Griffith, NuCana’s Founder and CEO, expressed his excitement, stating, “We are very excited to share these data on NUC-7738 in combination with pembrolizumab in PD-1 inhibitor refractory and resistant patients with melanoma. Outcomes in this patient population are very poor, with median progression-free survival of 2-3 months with the current standard of care, so we are very encouraged that the majority of patients who received this combination achieved a progression-free survival of more than five months.”
Beyond its efficacy, the combination of NUC-7738 and pembrolizumab demonstrated a favorable safety profile. NuCana believes that NUC-7738’s ability to target multiple aspects of the tumor microenvironment (TME) through disruption of RNA polyadenylation and subsequent changes to gene expression in cancer cells, may be the key to its success. Data from tumor biopsies taken before and after NUC-7738-based treatment revealed increases in genes related to antigen presentation and T-cell activation. This suggests that NUC-7738 may be able to sensitize PD-1-resistant tumors to rechallenge with PD-1 inhibitors.
While these results are promising, it’s important to note that NuCana discontinued their NuTide:323 study in August. This decision was based on a pre-planned initial analysis and recommendation from the study’s steering committee. Despite prognostic imbalances favoring the control arm, the committee determined that the combination of NUC-3373 with leucovorin, irinotecan, and bevacizumab was unlikely to achieve the study’s primary objective of superior Progression-Free Survival compared to the control arm.
The positive data from the NuTide:701 study has had a significant impact on NCNA stock, which surged by 166.50% during premarket trading on Monday. This surge highlights the market’s optimism about the potential of NUC-7738 and its potential to provide a new treatment option for patients with melanoma who have failed or relapsed on other therapies.
This study represents a significant step forward in the fight against melanoma and could potentially offer a new hope for patients with limited treatment options. As further research and clinical trials progress, we may see NUC-7738 emerge as a valuable tool in the arsenal of cancer treatments.
