The National Medical Products Administration (NMPA) of China has recently approved Pfizer’s third generation ALK inhibitor Borrena (lorlatinib) as the first-line treatment for adults with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Pfizer already has deep commercial experience in China’s NSCLC market, and this approval will further strengthen its position within the NSCLC market in China, says GlobalData, a leading data and analytics company.

According to GlobalData’s ‘Pharmaceutical Intelligence Center’, the number of diagnosed prevalent cases of ALK-mutant NSCLC in China is estimated to grow at a CAGR of 5.3% from 22,725 in 2021 to 31,902 in 2029.

Borrena (lorlatinib) is the second treatment for ALK-positive NSCLC patients in China from Pfizer. Another treatment, Xalkori (crizotinib), for ALK-positive NSCLC patients was launched in 2013 in China. However, Xalkori does not work well against brain metastases, whereas lorlatinib has better brain penetrating ability and has shown promising efficacy against brain metastases. In March 2021, lorlatinib received FDA approval for first-line treatment of ALK-positive advanced NSCLC, followed by EU approval in January 2022.

Prashant Khadayate, Pharma Analyst at GlobalData, comments: “Innovative targeted therapies in NSCLC have huge potential in China considering the patient pool available who can benefit from it irrespective of existing competition. However, ALK-positive NSCLC is a niche segment within NSCLC, and based on the number of such patients, lorlatinib is expected to face stiff competition in China.”

Earlier in September 2020, Pfizer invested US$200m for 9.9% stake in CStone to collaborate on the development and commercialization of CStone’s second-generation PD-L1 inhibitor, sugemalimab. Notably, in December 2021, Cejemly (sugemalimab) received approval in China for the first-line treatment of metastatic (stage IV) NSCLC in combination with chemotherapy and is the first PD-L1 therapy approved globally for the first-line treatment of metastatic non-squamous and squamous NSCLC.

In June 2021, CStone announced it would jointly develop lorlatinib with Pfizer for ROS1+ advanced NSCLC in Greater China as part of an ongoing partnership with Pfizer. This pivotal clinical study received investigational new drug (IND) approval in January 2022 in ROS1+ lung cancer in China. It is the world’s first pivotal study of lorlatinib in ROS1+ NSCLC.

Khadayate concludes: “Pfizer is consistently working towards improving its NSCLC drug portfolio in China through partnership and through its products to maximize market potential. For example, lorlatinib development in ROS1+ NSCLC will leverage CStone’s development capabilities combined with the commercialization capabilities of Pfizer. Overall, all these moves form part of Pfizer’s strategy to strengthen its position in the NSCLC market in China.”