Sesen Bio has reported positive preliminary efficacy results from its ongoing Phase III VISTA Trial assessing vicinium in patients with non-muscle invasive bladder cancer (NMIBC).

The data demonstrated that evaluable carcinoma in situ patients achieved clinically significant results at three, six, nine and 12 months of follow-up in the trial.

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It was also found that vicinium was generally well-tolerated by patients, with dysuria, hematuria and urinary tract infection being the commonly reported treatment-related adverse events.

Sesen Bio president and CEO Dr Thomas Cannell said: “The design of the VISTA trial aligns with FDA’s guidance for NMIBC drug development, and the findings are highly encouraging, demonstrating that treatment with vicinium results in clinically meaningful efficacy and favourable safety and tolerability.

“The findings are highly encouraging, demonstrating that treatment with vicinium results in clinically meaningful efficacy and favourable safety and tolerability.”

“Overall, the data reinforce our belief that vicinium is positioned to provide a valuable benefit to patients by treating their disease with long-term responses and extending their time to face such a decision as removing their bladder.

“2019 is set to be a transformational year for Sesen Bio, and we look forward to advancing the VISTA trial and assessing the full 12-month data from all patients later this year.”

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The VISTA trial is an open-label, multi-centre, single-arm study that has enrolled NMIBC patients who have been previously treated with bacillus Calmette-Guérin (BCG) and considered BCG-unresponsive.

Patients will receive locally administered vicinium twice a week for six weeks during the trial.

After completing the six-week period, patients will be treated with a once-weekly dose of vicinium for another six weeks and then every other week for up to two years.

The trial’s primary objective is the complete response rate in patients with carcinoma in situ with or without papillary disease.