Similar serious adverse event rate, clinical benefit seen for patients with versus those without a waiver
By Elana Gotkine HealthDay Reporter
MONDAY, July 8, 2024 (HealthDay News) — In a trial involving patients with therapy-refractory cancer treated with approved targeted or immunotherapies, matched to their tumor molecular profile but outside their registered indications, those for whom a waiver was granted had similar serious adverse event rates and clinical benefit rates as those who did not receive a waiver, according to a study published online June 27 in Clinical Cancer Research.
Jade M. van Berge Henegouwen, from Erasmus Medical Center in Rotterdam, Netherlands, and colleagues examined the impact of protocol waivers on treatment safety and efficacy in a multicenter, nonrandomized clinical basket trial treating patients with therapy-refractory cancer with molecularly targeted and immunotherapies outside their registered indications. All waivers granted were reviewed, analyzed in terms of safety and efficacy outcome, and compared to outcomes for patients who did not receive a waiver. Protocol waivers were granted for 82 of 1,019 eligible patients (8 percent) between Sept. 1, 2016, and Sept. 1, 2021.
The researchers found that 45 percent of waivers were granted for general or drug-related eligibility criteria; other categories included out-of-window testing, treatment exceptions, and testing exceptions. Patients who did and did not receive a waiver had a similar serious adverse event rate (39 versus 41 percent). The clinical benefit (objective response or stable disease ≥16 weeks) rate was 40 versus 33 percent for patients with versus without a waiver.
“The current data advocate that ‘old’ unnecessarily strict safety criteria should, where possible, be eliminated when setting-up new molecularly driven trials,” the authors write.
The trial was funded by multiple pharmaceutical companies.
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