29.1%/5.2%）。鳞癌受试者中中央型占比72.2%（在贝伐珠治疗过程中更易出现咯血副作用），两组的三级及以上和严重TRAE 并无明显差异（22.2%/18.9% vs. 18.7%/18.7%）。依沃西所有VEGF 相关AE 均为1-3 级，出血发生率略高于K 药组。考虑到出血风险显著抑制了贝伐珠在肺鳞癌患者中的应用，依沃西为鳞癌患者提供了可行的VEGF 靶向治疗方案。Evosimab's first head-to-head K drug phase III efficacy data is impressive: AK112-303/harmoni-2 study data was presented at the WCLC 2024 Presidential Symposium: PFS HR in the ITT population was 0.51 (mPFS: 11.14 vs. 5.82 months, with K drug data similar to MPFs in KEYNOTE-042), better than market expectations. The 9-month PFS rate 56% vs. 40%, respectively, and the PFS curve continued to widen as follow-up time increased; the ORR and DCR of the Evosi group were also significantly better (50.0% vs. 38.5%, 89.9% vs. 70.5%).
Statistically significant efficacy was achieved in all major subgroups: the PFS HR in subjects with low expression (TPS 1-49%) and high expression (TPS ≥ 50%) of PD-L1 was 0.54 and 0.46, respectively, 0.48 and 0.54 HR for squamous cell cancer and non-squamous cell carcinoma were 0.54 and 0.54, respectively, and HR for brain metastasis and liver metastasis were 0.55 and 0.47, respectively, all similar to the ITT population.
Safety was further verified, and the efficacy and risk characteristics of the product were excellent: the incidence of grade 3 and above TRAE and severe TRAE in the evossi group was 29.4%/20.8%, respectively (vs. 15.6%/16.1% in the K group, but lower than 57.9% of grade 3 and above TRAE in the LEAP-007 trial), and the incidence of TRAE leading to drug discontinuation/death was 1.5%/0.5%, or even lower than 3.0%/1.0% of the K group (LEAP-007:
29.1%/5.2%). Among squamous cell carcinoma subjects, the central type accounted for 72.2% (more likely to have hemoptysis side effects during treatment with bevazide), and there was no significant difference between grade 3 and above and severe TRAE between the two groups (22.2%/18.9% vs. 18.7%/18.7%). All VEGF-related AEs in EVOSIL were grade 1-3, and the bleeding rate was slightly higher than in the K group. Considering that the risk of bleeding significantly inhibits the use of bevacizumab in patients with lung squamous cell carcinoma, Evosil provided a viable VEGF-targeted treatment plan for patients with squamous cell carcinoma.
The target price was raised, and the September gold stock recommendation was reiterated: the company expects that Ivorian 1L PD-L1+ NSCLC will be approved in China on 1H25, and partner Summit will soon launch a global phase III trial Harmoni-7 to target first-line treatment for PD-L1 TPS ≥ 50% NSCLC. Based on excellent clinical data that exceeded expectations, we raised Iwasi's overseas development success rate and sales forecast (which mainly affects the company's long-term revenue forecast), and raised the DCF target price to HK$77.0 (previously HK$72.0), continuing to select the company as the industry's key recommended target and September gold stock.