Evgen concludes patient recruitment in STEM breast cancer trial

The AIM-traded firm described STEM as an open label trial that had regulatory approval to recruit 60 patients.

Following the “favourable” interim read-out, as announced on 11 June, the principal investigator and the company's medical adviser said they believed there was sufficient evidence to conclude that the main aims of the trial - a favourable safety and tolerability profile and evidence of clinical benefit - had been successfully met.

On that basis, Evgen said it had decided that there was no merit in recruiting the full number of patients allowed under the protocol.

As at 24 July, 50 patients had been enrolled in the trial, with any eligible patients currently in screening also being admitted to the trial.

All eligible patients would continue as per the trial protocol, and would receive SFX-01 until such point as they showed clinical progression or reached the end of the trial at six months.

If they received clinical benefit for the full duration of the trial, Evgen said that like all other patients in the trial, they would be eligible for entry into the compassionate use programme.

On that basis, the final readout would occur around the end of the calendar year, which would include details of the safety, tolerability and the clinical benefit rate observed across all patients.

“The STEM trial is an exploratory trial that was designed to demonstrate safety and tolerability with long-term exposure to SFX-01 and to provide evidence that it has anti-tumour activity after failure of at least one and up to three prior hormone therapies,” said principal investigator Dr Sacha Howell.

“With these objectives in mind, we have sufficient evidence to believe that SFX-01 warrants further investigation through the conduct of a randomised placebo-controlled trial.”

Dr Stephen Franklin, CEO of Evgen, added that the company was “excited” that so far, the data from its exploratory STEM trial supported further clinical evaluation of SFX-01, with the board “looking forward” to the final read-out around the end of the calendar year.

“The next step is likely to be a placebo-controlled trial, testing SFX-01 in combination with second-line hormone therapy in patients that have failed on CDK4/6 inhibitors.

“This is the initial setting for which we wish to see SFX-01 approved in metastatic breast cancer.”