[Madrid (Spain) = E-Daily Reporter Kim Jinsoo ] “The FGFR3-targeted antibody-drug conjugate (ADC) ‘BHV-1530 (AMB302)’ has demonstrated confirmed tumor responses in urothelial carcinoma and head and neck cancer. This can be considered a significant achievement that demonstrates the drug’s potential to be developed as a first-in-class new drug.”

Shodeinde Coker, Chief Medical Officer at U.S.-based Biohaven, offered this assessment of the Phase 1 clinical trial results for BHV-1530 presented at the European Society for Medical Oncology (ESMO) 2026. BHV-1530 is an FGFR3-targeted ADC for which South Korea’s Aimed Bio Inc. licensed the technology to Biohaven.

According to the study conducted by Biohaven, when doses ranging from 1 to 7 mg/kg were administered to 17 patients with advanced solid tumors, tumor shrinkage was observed in several cancer types—including urothelial carcinoma—in the group receiving 3.3 mg/kg or higher. No dose-limiting toxicities (DLTs) or serious treatment-related adverse events were reported, and the maximum tolerated dose (MTD) was not reached. The most common adverse events were nausea (35.3%) and fatigue (29.4%).

Chief Executive Officer Coker explained, “In particular, a response was confirmed in patients with urothelial carcinoma whose disease had progressed despite combination therapy with enfortumab vedotin and pembrolizumab,” adding, “It is significant that tumor responses were also observed in patients who had previously received conventional FGFR tyrosine kinase inhibitors (TKIs).”

These results are noteworthy in that they present a new treatment option for patients who have failed previous anticancer therapies. In particular, it is believed that ADCs—which target FGFR3 to deliver cytotoxic drugs—have the potential to overcome the limitations of existing FGFR inhibitors.

Safety data are also positive. He emphasized, “To date, we have not observed the toxicities typically associated with the existing class of FGFR inhibitors,” adding, “The differentiated safety profile and initial antitumor activity provide a basis for continuing further development.”

He took a cautious stance regarding the fact that an FGFR3-targeted ADC previously developed by Eli Lilly failed to demonstrate an objective response.

General Manager Coker said, “It is difficult to explain why no tumor response was observed in Lilly’s clinical trial,” but added, “The antitumor activity of an ADC depends on various factors, such as the antibody, payload, and linker. BHV-1530 differentiates itself from existing FGFR3 ADCs in all three of these areas.”

Regarding future development strategies, he explained, “We are currently finalizing the dose-escalation phase,” adding, “We plan to determine the recommended dose for subsequent clinical trials and proceed to an expansion cohort targeting urothelial carcinoma and other FGFR3-related tumors.”

Aimed Bio Inc. also noted that these clinical results are highly significant as they demonstrate the potential to overcome the limitations of existing FGFR3-targeted ADCs.

Min Byeong-gwi, Director of Aimed Bio Inc., explained, “BHV-1530 was designed with all three components—the antibody, linker, and payload—differing from Lilly’s existing FGFR3 ADC,” adding, “We have secured substantial evidence of its distinctiveness compared to Lilly’s candidate from the preclinical stage, and there was scientific evidence that it could demonstrate efficacy in actual clinical trials.”

In particular, it is significant that these clinical results demonstrate the competitiveness of “P-ADC,” Aimed Bio Inc.’s proprietary new drug development platform.

Director Min emphasized, “No matter how good a platform we claim to have, it is meaningless if it does not demonstrate efficacy in actual clinical trials. What is important is that the results anticipated in previous preclinical studies are now beginning to appear in actual patients.”

He continued, “Lilly administered the same FGFR3-targeted ADC at quite high doses but failed to confirm an objective tumor response. In contrast, BHV-1530 showed almost no adverse reactions—which had been a concern—even at high doses, and its antitumor efficacy was confirmed. This goes beyond simply demonstrating efficacy in a single ADC; it showcases the potential of the research approach based on the P-ADC platform.”

A key area to watch in future development is combination therapy with immuno-oncology drugs. Biohaven is currently conducting a clinical trial combining BHV-1530 with the PD-1 inhibitor Livtayo (semiplimab).

He explained, “FGFR3 is a promising anticancer target, but until now, there has been a lack of suitable drugs capable of effectively targeting it,” adding, “While the potential for combination therapy with immunotherapy was suggested in the past for FGFR3-targeting monoclonal antibodies or FGFR inhibitors, it was not fully realized due to the limited efficacy of monotherapy.”

Director Min continued, “Even before licensing the technology to Biohaven, we conducted preclinical studies on the combination of AMB302 and immunotherapy,” adding, “We confirmed highly encouraging tumor-suppressing effects, and this data was one of the key research findings presented during the technology licensing process.”

The schedule for the release of future clinical data is also taking shape. Director Min said, “Biohaven is scheduled to give an oral presentation on BHV-1530 at the upcoming ENA Triple Meeting in November,” adding, “We expect to provide more clinical updates than we did at this year’s ESMO.”