Innovent Biologics and Jiangsu Aosaikang Pharmaceutical (ASK Pharm) have secured China’s National Medical Products Administration (NMPA) approval for limertinib to treat a type of lung cancer.
In October last year, Innovent and ASK Pharm entered a strategic collaboration focused on limertinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
NMPA approved the partners’ New Drug Application (NDA) for limertinib to treat adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC).
Innovent and ASK Pharm also submitted a second NDA to NMPA for the treatment of advanced NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations.
Innovent senior vice president Hui Zhou said: “The approval of limertinib’s first indication marks a significant milestone, providing new treatment options for T790 mutation-positive lung cancer patients who have progressed after previous EGFR-TKI treatments.
“We look forward to working with ASK Pharm to bring limertinib to market and benefit Chinese patients with EGFR-mutated NSCLC.”
ASK Pharm CEO and executive director Jingfei Ma said: “Together with Innovent, we look forward to limertinib benefiting more Chinese lung cancer patients in the near future.
“The first approval of limertinib, a Class I innovative product, represents significant progress in the company’s transformation toward innovative drug research and development.”
The drug showed success in a multi-centre, randomised, double-blind, controlled Phase 3 clinical trial compared to gefitinib to treat patients with EGFR mutation-positive NSCLC.
Also, a Phase 2b study in 301 patients with locally advanced or metastatic EGFR T790M-mutated NSCLC showed limertinib’s efficacy and safety profile.
The drug showed an overall response rate (ORR) of 68.8% and a disease control rate (DCR) of 92.4%, as assessed by an independent review committee (IRC).
It also showed a median progression-free survival (PFS) of 11 months, with a median duration of response (DoR) of 11.1 months.
In addition, limertinib met its primary endpoint in the Phase 3 study compared to gefitinib for first-line treatment of locally advanced or metastatic NSCLC with EGFR mutations.
Phase 2b and Phase 3 clinical studies principal Investigator Shi Yuankai said: “Limertinib has demonstrated significant efficacy and safety in NSCLC patients with EGFR T790M mutation and EGFR-sensitive mutations.
“Patients treated with limertinib showed a reduced risk of CNS progression or death. This approval brings new hope and options to patients with advanced EGFR-mutated NSCLC in China.”
In a separate development, Innovent announced that China’s NMPA Centre for Drug Evaluation (CDE) has granted Breakthrough Therapy Designation (BTD) for IBI343.
IBI343 is an advanced TOPO1i anti-CLDN18.2 ADC, as monotherapy to treat CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) patients.
CDE granted the breakthrough designation for IBI343 based on data from an ongoing Phase 1 study conducted in China, Australia, and the US.
The study showed favourable safety and tolerability, along with promising antitumor activity of IBI343 monotherapy in advanced PDAC patients.
Innovent senior vice president Hui Zhou said: “As the world’s first CLDN18.2 ADC to receive BTD in this difficult-to-treat cancer, IBI343 monotherapy has shown encouraging efficacy and tolerable safety in late-line treatment of patients with advanced pancreatic cancer.
“Subject to PoC data readout, we plan to initiate pivotal MRCT studies to further confirm its efficacy and safety in this indication.
“Additionally, we will also explore the potential of IBI343 in combination therapy for pancreatic cancer and other solid tumours, including gastric cancer.”
