Elevar Therapeutics Achieves First Patient Dosing in Phase 2 Lirafugratinib Study Across Non-CCA Solid Tumors

With a PDUFA date of September 27, 2026 already set for lirafugratinib's new drug application in cholangiocarcinoma, Elevar Therapeutics has now dosed the first patients in ReFocus202, a global Phase 2 study extending the FGFR2 inhibitor's evaluation into non-CCA solid tumors harboring FGFR2 fusion or rearrangement. For oncology manufacturers and CDMOs tracking potential scale-up obligations, the parallel NDA review and expanded clinical program represent a compressed timeline that warrants early capacity planning.

The open-label, single-arm trial (Protocol ID ELE-4008-202; NCT07359820) enrolled its first patient at Samsung Medical Center in Seoul, South Korea, and its second at Moffitt Cancer Center in Tampa, Florida. Sites across the U.S., South Korea, the UK, Spain, and France are participating. The primary endpoint is objective response rate, with Elevar targeting an interim analysis across at least seven tumor types with a minimum of five patients per type.

The clinical rationale draws directly from the earlier Phase 1/2 ReFocus study, in which 42 non-CCA patients representing 13 tumor types demonstrated measurable antitumor activity with lirafugratinib. ReFocus202 is designed to confirm tumor-agnostic efficacy of selective FGFR2 inhibition, independent of cancer origin. Dr. Richard Kim, principal investigator and service chief of medical gastrointestinal oncology at Moffitt Cancer Center, noted that patients with advanced FGFR2-altered solid tumors outside CCA face limited therapeutic options, framing the study as an opportunity to define a broader eligible population.

Lirafugratinib holds Orphan Drug and Fast Track designations from the FDA for CCA. The NDA under Priority Review covers patients with CCA harboring FGFR2 fusion or rearrangement who have received prior therapy. A potential approval in late September 2026 would place immediate commercial manufacturing and supply-chain demands on any CDMO or internal facility supporting the program, particularly given the concurrent enrollment activity across five countries.

Elevar intends to use ReFocus202 data alongside the existing ReFocus dataset to build a regulatory submission supporting the drug's tumor-agnostic profile, a pathway that will require robust analytical comparability and consistent process controls across a geographically distributed clinical supply chain.

Enrollment completion across all ReFocus202 sites, and the interim analysis readout spanning at least seven tumor types, will serve as the next measurable checkpoints for operations and regulatory teams monitoring this program's trajectory.

Source: Elevar Therapeutics via GlobeNewswire, June 22, 2026.