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A nanoengineered cisplatin-releasing patch called PRV111 achieved a 95.5% pathologic complete response rate in patients with early-stage oral cancer or high-grade dysplasia — and every single patient avoided surgery. With no recurrences at a median 14-month follow-up and negligible systemic side effects, the patch could reshape how early oral cancer is treated.
A topical, self-adhesive patch that slowly releases the chemotherapy drug cisplatin is showing remarkable results in early-stage oral cancer. In the ongoing CLN-004 phase 2 trial, PRV111 achieved a 95.5% pathologic complete response (pCR) rate in 22 evaluable patients with noninvasive oral cancer or high-grade dysplasia — and the one patient who didn't achieve a full response was still downstaged to low-grade dysplasia. All patients avoided their planned surgeries, and treated tissue healed completely with no scarring.
Durability is also looking strong. At a median follow-up of 14 months, no recurrences have been observed, and the longest ongoing response has surpassed 21 months. The safety profile is equally encouraging — systemic cisplatin exposure was negligible, no serious adverse events occurred, and 85% of treatment-related side effects were mild and transient.
By the Numbers:
Why it matters: Patients with early oral cancer currently face repeated surgical resections that can permanently impair speech and swallowing. PRV111 offers a non-surgical alternative that clears disease while preserving tissue function — a potential game-changer for the standard of care.