ESMO Congress 2026

Antibody-drug conjugates (ADCs) have become one of the most active classes in breast cancer therapy ^[10]. In the published phase 3 TROPION-Breast01, Dato-DXd versus investigator's choice of chemotherapy significantly reduced the risk of progression or death in HR+/HER2- breast cancer with one to two prior lines of chemotherapy in the advanced setting (PFS HR 0.63) ^[7]; the same ESMO also features the phase 3 HORIZON-Breast06 of SHR-A1811 in HER2-low disease ^[1] and the phase 3 PANKU-Breast01 of izalontamab brengitecan in HR+/HER2- disease ^[6] — this track is already crowded.

This report covers APEX-Breast01 (LBA27) ^[5]: TQB2102, a biparatopic HER2 ADC from Chia Tai Tianqing (under China Pharma, CTTQ per the post), versus chemotherapy in HER2-low recurrent/metastatic breast cancer. Per the live posts: 543 patients with no prior chemotherapy in the recurrent or metastatic setting were randomized to TQB2102 7.5 mg/kg Q3W or TPC (capecitabine/paclitaxel/nab-paclitaxel), data cutoff May 31, 2026; median PFS 16.4 vs 5.5 months, HR 0.29, p<0.0001 (consistent in both HR+/HER2-low and all HER2-low), ORR 68.8% vs 31.0%; OS HR 0.44, though posters noted OS data remain immature. One live comment summed it up as "new ADC, same ~0.3 hazard ratio" and called for head-to-head trials.

The main-site news independently reported the same results, consistent with the live posts: risk of progression or death reduced by 71%, with treatment-related ILD rate of 2.2% as a key safety figure added by the news; another news item further gave the 95% CIs for the two HRs (0.22–0.39 and 0.22–0.38). The news also noted the study was presented as LBA27 in a proffered oral session on October 23, with Leading PIs Prof. 王树森 of 中山大学肿瘤防治中心 and Prof. 张清媛 of 哈尔滨医科大学附属肿瘤医院; one news piece called it "the world's first successful phase 3 of a biparatopic HER2 ADC in this indication"; a live post added that an NDA has been submitted in China (the English name Rolditamig DXd appearing in a post is to be confirmed).

The step forward: with its differentiated biparatopic antibody design, TQB2102 delivered an HR of 0.29 and median PFS of 16.4 months in a HER2-low population with no prior chemotherapy for advanced disease, echoing the efficacy magnitude established by monoparatopic HER2 ADCs and offering an option beyond chemotherapy. The limitations are equally clear: OS remains immature; the exact figure for grade ≥3 neutropenia was truncated in the live posts, so full safety beyond the news-reported ILD 2.2% awaits the full publication; and as the live comment noted, its position versus peer ADCs ultimately needs head-to-head trials.