On Saturday, NuCana plc (NASDAQ:NCNA) presented final data from the Phase 2 NuTide:701 study at the ESMO Congress on NUC-7738 in combination with Merck & Co Inc's (NYSE:MRK) Keytruda (pembrolizumab) for metastatic melanoma who were refractory to or had relapsed on prior PD-1 inhibitor therapy.
In this 12-patient cohort, most patients had received at least two prior lines of PD-1 inhibitor therapy.
Nine out of twelve (75%) achieved disease control, including two patients who achieved Partial Responses.
One of these patients, who had received two prior lines of PD-1 inhibitor-based therapy and had progressed on their latest treatment of ipilimumab plus nivolumab within two months, achieved a 55% reduction in tumor volume.
Seven of the 12 patients had a progression-free survival time of over five months.
Hugh Griffith, NuCana's Founder and CEO, said, "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."
In addition to achieving these encouraging efficacy signals, the combination of NUC-7738 and pembrolizumab had a favorable safety profile.
The company says NUC-7738 can sensitize PD-1-resistant tumors to rechallenge with PD-1 inhibitors due to its ability to target multiple aspects of the tumor microenvironment (TME) via the disruption of RNA polyadenylation and subsequent changes to gene expression in cancer cells.
Data from tumor biopsies obtained before and after NUC-7738-based treatment demonstrated increases in genes related to antigen presentation and T-cell activation.
In August, NuCana discontinued NuTide:323 study following a pre-planned initial analysis and recommendation from the NuTide:323 Study Steering Committee.
While there were prognostic imbalances favoring the control arm, the Steering Committee believed that the combination of NUC-3373 with leucovorin, irinotecan, and bevacizumab (NUFIRI+bev) was unlikely to achieve the study's primary objective of superior Progression-Free Survival compared to the control arm of 5-FU, leucovorin, irinotecan, and bevacizumab (FOLFIRI+bev) in the final analysis.
Price Action: NCNA stock is up 166.50% at $6.62 during the premarket session at last check Monday.
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