Johnson & Johnson/Legend Biotech Announce Positive Phase 3 CAR-T Results; Dupilumab Approved in EU for COPD; CStone and Hengrui Enter Commercialization Deal for Avapritinib

On July 3, Johnson & Johnson and Legend Biotech jointly announced positive results from the pre-specified second interim analysis of the Phase 3 CARTITUDE-4 study. This study evaluated Carvykti (ciltacabtagene autoleucel, cilta-cel), a chimeric antigen receptor (CAR) T-cell therapy co-developed by the two companies, compared to standard therapy for the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma (MM) after one prior line of therapy.

CARTITUDE-4 is an international, randomized, open-label Phase 3 study designed to evaluate the efficacy and safety of Carvykti versus standard treatment regimens in adult patients with relapsed multiple myeloma (MM) who are lenalidomide-resistant and have received 1-3 prior lines of therapy. The standard treatment regimens in the study include pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).

Interim analysis shows that, compared with standard therapy, patients receiving Carvykti have statistically and clinically meaningful improvement in overall survival (OS). Detailed data will be presented at upcoming medical conferences and submitted to global regulatory authorities.

According to the press release, Carvykti is the first B-cell maturation antigen (BCMA)-targeted CAR-T therapy approved for second-line or later treatment of multiple myeloma patients.

On July 3, Sanofi and Regeneron jointly announced that dupilumab (trade name: Dupixent) has been approved by the European Medicines Agency (EMA) as an add-on maintenance treatment for patients with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophil levels, including those already using a combination of inhaled corticosteroids (ICS), long-acting beta2-agonists (LABA), and long-acting muscarinic antagonists (LAMA).

The positive results of the BOREAS study and NOTUS study were the main basis for this approval.

Results from the BOREAS study (n=939) showed that the frequency of moderate to severe COPD exacerbations in patients treated with dupilumab decreased by 30% over 52 weeks (0.78 vs. 1.10, p<0.001). Meanwhile, at week 12, the forced expiratory volume in 1 second (FEV1) in the dupilumab group increased by 160 mL from baseline, compared to 77 mL in the placebo group (least squares mean difference of 83 mL, p<0.001).

NOTUS Study (n=935) Results Showed that the Frequency of Moderate to Severe COPD Exacerbations in the Dupilumab Group Was Reduced by 34% Over 52 Weeks (0.86 vs. 1.30, p<0.001). Meanwhile, at Week 12, the FEV1 in the Dupilumab Group Increased by 139mL from Baseline, Compared with 57mL in the Placebo Group (Least Squares Mean Difference: 82mL, p<0.001).

Notably, the EMA is the world's first regulatory authority to approve Dupixent for COPD patients, while other regulatory agencies worldwide, including those in the United States, China, and Japan, are reviewing additional submissions.

On July 3, CStone Pharmaceuticals announced that it had reached an agreement with Hengrui Pharma to grant the latter the exclusive promotion rights for the precision treatment drug Avapritinib Tablets in mainland China. CStone Pharmaceuticals will continue to retain the rights to research and development, registration, production, and distribution of Avapritinib Tablets in mainland China. According to the terms of the agreement, CStone Pharmaceuticals will receive an upfront payment of 35 million RMB, and Hengrui Pharma will subsequently pay service fees to CStone Pharmaceuticals.

Avapritinib is a potent, highly selective, oral kinase inhibitor targeting KIT and PDGFRA mutations. It was approved for marketing by China's National Medical Products Administration (NMPA) in March 2021 for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring PDGFRA exon 18 mutations (including PDGFRA D842V mutations). The product was co-developed by CStone Pharmaceuticals and its partner Blueprint Medicines. In 2018, CStone Pharmaceuticals entered into an exclusive collaboration and licensing agreement with Blueprint Medicines, obtaining exclusive rights to develop and commercialize avapritinib tablets in Greater China (including mainland China, Hong Kong, Macau, and Taiwan).

In the United States, avapritinib has been approved by the FDA for the treatment of three indications, specifically: adult patients with unresectable or metastatic GIST harboring PDGFRA exon 18 mutations (including PDGFRA D842V mutations); adult patients with advanced aggressive systemic mastocytosis (SM), SM with associated hematological neoplasms (SM-AHN), mast cell leukemia (MCL), and indolent systemic mastocytosis (ISM).

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