announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for Ivonescimab (PD-1/VEGF bispecific antibody, AK112) combined with docetaxel for the treatment of locally advanced or metastatic Non-Small-Cell Lung Carcinoma (NSCLC) patients who failed to respond to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy. This is the third BTD for AK112 for use with NSCLC patients, and AK112 is the only drug candidate granted BTD for PD-(L)1 resistant lung cancer treatment in China.The three BTDs of AK112 comprise:
- AK112 combined with chemotherapy for the treatment of EGFR-mutated locally advanced or metastatic NSCLC patients who have failed to respond to EGFR-TKI treatment, which has completed Phase III clinical trials patient enrollment.
- AK112 as the first-line treatment for locally advanced or metastatic NSCLC patients with positive PD-L1 expression, which has entered into Phase III clinical trials.
- AK112 combined with docetaxel for the treatment of locally advanced or metastatic NSCLC patients who failed to respond to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy, which is the only drug candidate granted BTD for PD-(L)1 resistant lung cancer treatment in China.
Breakthrough Therapy Designations aim to accelerate development and regulatory review of new drugs to treat severe diseases which show encouraging preliminary clinical results. These drugs need to demonstrate a significant improvement in clinical endpoints over existing therapies, or fulfill unmet medical needs. Akeso believes that these three designations of AK112 for NSCLC will accelerate the R&D and marketing progress of AK112 in China.
PD-1/L1 monoclonal antibody combined with platinum-based chemotherapy is the standard of care for first-line therapy for patients with advanced NSCLC. However, the majority of patients do not benefit from the treatment or may relapse after a period of response, highlighting the need for more effective treatment. However, there are currently no immunotherapy regimens approved for NSCLC patients who failed to respond to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.
Immunotherapy plus anti-angiogenesis therapy has proven its combined advantages in previous studies worldwide. Lung cancer is one of the mainstream exploration areas of this therapy. AK112 can potentially simultaneously block PD-1 and VEGF targets, and has demonstrated a favorable safety profile and promising anti-tumor efficacy in recent studies conducted by the Company. AK112 is expected to provide a valuable option for NSCLC patients to overcome immunotherapy resistance antibody therapy.
ABOUT IVONESCIMAB (PD-1/VEGF BI-SPECIFIC ANTIBODY, AK112)
Ivonescimab is a first-in-class and the first to enter phase III clinical trial PD-1/VEGF bi-specific antibody independently developed by Akeso Biopharma. Engineered with our unique Tetrabody technology, Ivonescimab blocks PD-1 binding to PD-L1 and PD-L2, and blocks VEGF binding to VEGF receptors. PD-1 antibody combined with VEGF blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma, non-small cell lung cancer and hepatocellular carcinoma). In view of the co-expression of VEGF and PD-1 in the tumor microenvironment, Ivonescimab, as a single agent to block these two targets, may block these two pathways more effectively and enhance the antitumor activity, as compared to combination therapy.
Currently, Akeso is conducting a phase III clinical trial of AK112 monotherapy versus Pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, a phase III clinical trial of AK112 plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy is ongoing. AK112 has started multiple clinical trials for various stages treatment of indications including non-small cell lung cancer and small cell lung cancer