Viralytics Ltd (AX:VLA)’ presentations at AACR highlighted an impressive 36% response rate when melanoma patients refractory to the best available PD1/L1 checkpoint inhibitor therapy were treated with its Cavatak virotherapy plus Yervoy. It has expanded the Phase Ib MITCI trial to recruit an extra 44 patients who have failed prior PD1/L1 therapy, which could put it on track to a pivotal study or even provide a potential pathway to accelerated approval.
The CAPRA study of Cavatak plus Keytruda in melanoma was expand to enrol up to 50 patients following a 60% response rate in the first 15 assessable patients. We increase success probability for Cavatak from 35% to 40% and lift our valuation to A$408m or A$1.70/share from A$385m.
Compelling benefit from Cavatak/Yervoy combo
The tumour response rate in the first 22 melanoma patients receiving Cavatak plus Yervoy in the MITCI trial is substantially higher than the response rates for either Cavatak or Yervoy on their own reported from previous studies (28% and 11% respectively). Importantly, there was a 36% response rate among a subgroup of 11 patients who had failed prior treatment with the best available immune checkpoint inhibitor (ICI) therapies. The combination was well tolerated with only 8% of patients reporting serious treatment-related adverse events.
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