Congress runs Oct 23-27 in Madrid; Phase 2/3 biliary tract cancer trial data for tobevimig slated for oral presentation on Oct 24.
Early-stage data from ABL Bio, Hanmi Pharmaceutical, and Aimed Bio; HLB to present three oncology studies.
South Korean pharmaceutical and biotechnology companies are preparing to showcase their latest oncology clinical trial data at the upcoming European Society for Medical Oncology (ESMO) annual meeting. The presentations will cover a broad spectrum of research, from randomized controlled trials in biliary tract cancer patients to early-stage studies of bispecific antibodies and antibody-drug conjugates (ADCs), alongside supplementary analyses evaluating the efficacy and safety of existing trials.
Scheduled for October 23–27 (local time) in Madrid, Spain, ESMO 2026 will feature clinical data from ABL Bio, Hanmi Pharmaceutical, Aimed Bio, and HLB, among others.
ABL Bio’s bispecific antibody tobevimig (ABL001) has been selected for an oral presentation detailing the results of its Phase 2/3 biliary tract cancer trial. Its U.S. partner, Compass Therapeutics, will present the findings of the 'COMPANION-002' study on October 24. The trial compares the combination of tobevimig and paclitaxel versus paclitaxel monotherapy in previously treated patients with advanced biliary tract cancer.
According to results released last April, the median progression-free survival (PFS) in the combination arm was 4.7 months, compared to 2.6 months in the monotherapy arm, showing a statistically significant difference. However, overall survival (OS) did not reach statistical significance. Compass explained that survival analyses were impacted by factors such as more than half of the control group patients crossing over to the tobevimig combination therapy following disease progression.
Discussions regarding the regulatory approval process are currently underway. Compass announced on September 22 that the U.S. Food and Drug Administration (FDA) recommended conducting a trial demonstrating survival benefits prior to submitting a Biologics License Application (BLA). The company maintains that it can proceed with a marketing application without additional trials based on existing clinical data and high unmet medical need, and stated it will continue preparations and consultations with the FDA.
ABL Bio will also unveil early-stage clinical data for ABL111 and ABL503, which are co-developed with U.S.-based Novabridge Biosciences. ABL111 simultaneously targets Claudin 18.2 and 4-1BB, a receptor involved in immune cell activation. On October 25, the company will present additional safety and efficacy data from a Phase 1b trial evaluating ABL111 in combination with nivolumab and chemotherapy as a first-line treatment for metastatic gastroesophageal junction cancer. The candidate is also currently being evaluated in a Phase 2 combination trial.
ABL503 is a bispecific antibody targeting both PD-L1 and 4-1BB. Data set for presentation on October 23 will focus on dose optimization in solid tumor monotherapy, reviewing dosing conditions based on data secured from the Phase 1 trial.
Hanmi Pharmaceutical will showcase Phase 1 clinical data for BH3120, a bispecific antibody targeting the same pathway as ABL503. This presentation will cover results from the dose-escalation portion of the monotherapy in patients with advanced solid tumors. Additionally, Hanmi will present Phase 1 data for HM97662, a dual EZH1/EZH2 inhibitor, focusing on dose-dependent clinical data obtained from biomarker-selected patients with advanced or metastatic solid tumors.
In the ADC sector, Aimed Bio is scheduled to present follow-up Phase 1 data on October 23 for AMB302/BHV-1530, an FGFR3-targeting candidate licensed out to U.S.-based Biohaven. The dose-escalation study evaluates safety and preliminary antitumor activity in patients with advanced solid tumors.
Biohaven previously reported that preliminary antitumor activity was observed not only in tumors harboring FGFR3 genetic alterations but also in tumors with FGFR3 overexpression lacking such mutations. The upcoming presentation will provide further insights from this trial.
Elevar Therapeutics, the U.S. subsidiary of HLB, will present three studies related to its oncology portfolio. On October 26, the company will deliver a rapid oral presentation on the results of the 'THRIVE' Phase 2 study evaluating the efficacy and safety of rivoceranicib in previously treated patients with metastatic thymic epithelial tumors.
In the field of liver cancer, a subgroup analysis of the Phase 3 CARES-310 trial evaluating the combination of rivoceranicib and camrelizumab will be displayed via a poster presentation on October 25. The study investigated the correlation between early antibiotic use and therapeutic outcomes in patients treated with the combination therapy versus the comparator drug sorafenib.
Furthermore, a post-hoc safety analysis from the ReFocus trial of lirafugratinib will be presented as an electronic poster, detailing the correlation between prior immunotherapy exposure and the risk of mucosal and cutaneous adverse events.
The upcoming presentations encompass a diverse range of studies, spanning comparative trials tied to regulatory filings, early-stage evaluations of bispecific antibodies and ADCs, and sub- and post-hoc analyses of legacy trials. Key takeaways include interpreting survival data for tobevimig, confirming safety and optimal dosing for early-stage candidates, and identifying factors associated with therapeutic efficacy and adverse events in exploratory analyses. The significance of these findings will vary depending on the specific objective and developmental stage of each research program.
