Kang Fang Biology (09926): Harmoni-6 study results of the first-line treatment of advanced SQ-nsclc with evasil combined chemotherapy compared with tiramib combined with chemotherapy were published in Lancet & 2025 ESMO

According to Zhitong Finance App News, Kang Fang Biology (09926) announced that the results of the Harmoni-6/AK112 — 306 study were announced by Professor Lu Shun, director of the Department of Oncology at Shanghai Chest Hospital, at the 2025 European Society of Medical Oncology (ESMO) Chairman Forum, and published simultaneously in the main issue of the top international medical journal “THE LANCET” (THE LANCET).

Harmoni-6/AK112 — 306 (CTR20231272/NCT 05840016) is a randomized, controlled, multicenter phase III clinical study evaluating first-line treatment of advanced SQ-nsCLC with EVOSIL in combination with chemotherapy. The main end point of this study was progression-free survival (PFS) assessed by IRRC based on RECIST v1.1, and the key secondary endpoint was overall survival (OS). A total of 532 subjects were enrolled in the Harmoni-6 study, with a balanced baseline between the two groups. The clinical stage of 92.3% of the participants was stage IV; the characteristics of squamous cell carcinoma were in line with clinical reality, with central squamous cell carcinoma accounting for about 63%, consistent with the distribution of patients in the real world; the PD-L1 expression ratio was in line with clinical reality. The test results showed that:

Evosil combined chemotherapy reached the main PFS study end point compared with tiralizide combined with chemotherapy, and obtained decisive strong positive results. It had significant statistical benefits and significant clinical benefits. The evosil group significantly prolonged the PFS of patients compared to the control group.

PFS HR = 0.60, P50.0001 between groups of evosil in combination with chemotherapy and tirelizide in combination with chemotherapy. The median PFS (m PFS) in the Evosi group lasted 11.14 months, and m PFS in the control group was 6.9 months. The Harmoni-6 study achieved an improvement in absolute PFS between groups △ pFS = 4.24 months

In various subgroups, evosil combined chemotherapy significantly benefited over tirelizumab combined chemotherapy, including people regardless of PD-L1 expression level (PD-L1 positive or negative), with or without liver metastases, and regardless of the number of sites of baseline metastases.

In the PD-L1 negative (TPS51%) population, m PFS 9.9 months vs. 5.7 months, PFS HR = 0.55 (95% CI: 0.37, 0.82). In the PD-L1 positive (TPS ≥ 1%) population, m PFS 12.6 months vs. 8.6 months, PFS HR = 0.66 (95% CI: 0.46, 0.95). In people with liver metastases, PFS HR = 0.53; in people without liver metastases, PFS HR = 0.64. PFS HR = 0.46 for people with a baseline number of transfer sites greater than 3; PFS HR = 0.64 for people with a baseline number of transfer sites 53.

The overall safety of the Evosi group was good, and no new safety signals were found. The incidence of treatment-related serious adverse events and the incidence of grade 3 and above bleeding events were similar to those in the control group.

The New Indication Marketing Application (SNDA) for first-line treatment of Sq-nsCLC with evossi combination chemotherapy has now been accepted by CDE and is being reviewed, which is expected to bring hope to more patients. The results of this clinical study prove that the combined chemotherapy regimen has breakthrough clinical value compared to the PD-1 combination chemotherapy regimen, filled the clinical gap of the anti-angiogenic drug bevacizumab in the treatment of SQ-nsCLC, once again strongly demonstrated the excellent efficacy and good safety of evosi therapy, and consolidated the global leadership of evasil.

Harmoni-6/AK112 — 306 (CTR20231272/NCT 05840016) is a randomized, controlled, multicenter phase III clinical study evaluating first-line treatment of advanced SQ-nsCLC with evossi combined chemotherapy versus first-line treatment with relilizib. The main end point of this study was PFS assessed by IRRC based on RECIST v1.1, and the key secondary endpoint was OS. A total of 532 subjects were enrolled in the HarmonI-6 study, with a balanced baseline between the two groups. The clinical stage of 92.3% of participants was stage IV; the characteristics of squamous cell carcinoma were in line with clinical reality, with central squamous cell carcinoma accounting for about 63%, consistent with the distribution of patients in the real world; the PD-L1 expression ratio was in line with clinical reality.