Orient Securities: Innovative Drugs Break Through Multiple Paths, Domestic Innovation Reshapes New Standards

The Zhitong Finance App learned that Orient Securities released a research report saying that the WCLC conference further verified that innovative domestic drugs have gradually entered the stage of random control, global development and front-line expansion in the field of lung cancer from early single-arm data. The lung cancer treatment pattern is being dominated by traditional chemotherapy, first-generation IO, etc., and is evolving into multi-path competition for ADC, second-generation IO, and next-generation targeted drugs. It is recommended to focus on companies with differentiated efficacy, safety, and potential for global development.

Orient Securities's main views are as follows:

SCLC: The B7-H3 ADC Era Is Coming

Both phase III studies, TAISHAN-302 and ARTEMIS-008, yielded positive results. YL201 and HS-20093 significantly improved PFS and OS compared to topotecan. The OSHR in both studies was 0.46. B7-H3 ADC is expected to become the new standard treatment for recurrent SCLC. Furthermore, the first-line ORR of YL201 combined with sululimab in the first-line treatment of ES-SCLC reached 85.4%, and DB-1311 combined with pumitamig reached 92.3% in SCLC. B7-H3 ADC is expanding from second-line monotherapy to first-line combined immunity. The bank believes that the implementation of phase III survival benefits will drive B7-H3 ADC to become an important force in changing the SCLC treatment pattern, and subsequent global testing and frontline development are expected to further release clinical value.

Non-agansCLC: First-line treatment competition intensifies

Harmoni-2 updated OS results. Compared with pabolizumab, evosimab extended MOS in PD-L1-positive nsCLC patients from 22.6 months to 30.8 months (HR = 0.73, P = 0.009), promoting PD-1/VEGF double antibody to further benefit OS from PFS efficiency. At the same time, the CORR of rC148 combined chemotherapy in squamous cell cancer and non-squamous cell carcinoma reached 76.7% and 72.4%, respectively, and the overall ORR of LBL-024 combined chemotherapy reached 71.0%, and ADC combined immunization programs such as SYS6010 and YL201 also revealed positive data. The bank believes that first-line treatment of non-agansCLC is being expanded from traditional IO monotherapy or immunochemotherapy to multi-mechanism combination schemes such as second-generation IO combined chemotherapy and ADC combined immunization, and that second-generation IO and ADC will jointly promote the continuous iteration of first-line treatment standards.

AGANSCLC: EGFR and KRAS are progressing positively

In the field of EGFR mutations, updated data from Harmoni showed that the MOS for 16.8 months (HR = 0.76) in third-generation EGFR-TKI-treated patients was MOS of 16.8 months (HR=0.76); iza-Bren had a corr of 29.6% in the 2.5 mg/kg group among patients treated with EGFR-TKI. In the field of KRAS mutations, the ORR of the HS-10370 first-line combination protocol reached 81.5%. The CORR and MPFS of GFH375 were 52.1% and 8.3 months, respectively, in the treated KrasG12D mutant nsCLC. QLC1101 also showed initial anti-tumor activity. The bank believes that the pattern after third-generation TKI resistance is changing, and second-generation IO and ADC are expected to become new choices; the KRAS-mutant NSCLC is moving forward along the two paths of G12C-targeted drugs and the development of G12D inhibitors in later clinical trials.

Risk Alerts

Risk of failure in innovative drug development; risk of increased market competition; risk of commercialization of innovative drugs, etc.