Innovent Biologics announced that the non-covalent (reversible) Bruton's Tyrosine Kinase (BTK) inhibitor, Jaypirca (pirtobrutinib), has received approval by the National Medical Products Administration (NMPA) in China for a new indication to treat adult patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) after at least one line of systemic therapy including a BTK inhibitor.

Pirtobrutinib is a highly selective kinase inhibitor that utilises a novel non-covalent binding mechanism to extend the benefit of targeting the BTK pathway in CLL/SLL patients previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib or zanubrutinib). Pirtobrutinib received approval from the US FDA in January 2023 as a non-covalent (reversible) BTK inhibitor. In October 2024, pirtobrutinib was approved in China as a monotherapy for the treatment of adult patients with relapsed or refractory Mantle Cell Lymphoma (MCL) who have previously received at least two prior systemic therapies, including a BTK inhibitor.

Professor Lu-Gui Qiu, Principal Investigator of the BRUIN CLL-321 study in China, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, stated, "BTK inhibitors have become the preferred first- or second-line treatment for patients with CLL/SLL, yet some patients still experience disease progression and have a poor prognosis. Studies have shown that the median Overall Survival (OS) for patients after discontinuing a covalent BTK inhibitor is only about 22.7 months. Therefore, there is an urgent clinical need for new treatment. As a next-generation, non-covalent and reversible BTK inhibitor, pirtobrutinib represents an important advancement for patients with relapsed or refractory CLL. The BRUIN CLL-321 study demonstrated its therapeutic potential in CLL/SLL. We believe it will offer an important treatment option for patients with CLL/SLL in China and help meet the needs of long-term disease management in the future."

The approval of this new indication is based on results from the international, multicentre, randomised, phase-III BRUIN CLL-321 study. BRUIN CLL-321 is the world's first randomised phase-III trial conducted in patients with CLL/SLL who had previously been treated with a covalent BTK inhibitor (cBTKi). The study enrolled a total of 238 patients and evaluated the efficacy and safety of pirtobrutinib monotherapy versus investigator's choice of IdelaR (idelalisib plus rituximab) or BR (bendamustine plus rituximab).

Dr Li Wang, Lilly Corporate Senior Vice President, Head—Lilly China Drug Development and Medical Affairs Centre, stated, "The approval of pirtobrutinib for the CLL/SLL indication in China marks an important milestone in the treatment journey for Chinese CLL/SLL patients. It means that patients who continue to experience disease progression after covalent BTK inhibitor therapy can now gain timely access to this globally innovative treatment option. Supported by the efficacy and safety demonstrated in the BRUIN CLL-321 study, we are pleased to offer a new therapeutic choice for CLL/SLL patient population with significant unmet medical needs in China. Looking ahead, Lilly will remain committed to accelerating the introduction of cutting-edge therapies to help patients with hematologic malignancies in China achieve longer and better quality of survival. This is our enduring commitment to patients in China."

The results demonstrated that pirtobrutinib prolonged median Progression-Free Survival (PFS) compared with the investigator's choice regimen (14 months v/s 8.7 months; HR = 0.54). In addition, the discontinuation rate due to treatment-related adverse events was lower with pirtobrutinib (5.2 percent v/s 21.1 percent), further supporting its efficacy and tolerability advantages in patients previously treated with a covalent BTK inhibitor.

Dr Hui Zhou, Chief R&D Officer of Oncology, Innovent, stated, "Jaypirca (pirtobrutinib) is a next-generation, non-covalent (reversible) BTK inhibitor. It offers a novel treatment option for patients who have previously received covalent BTK inhibitor therapy. The approval in China for CLL/SLL represents a significant breakthrough in this field, which ensures that CLL/SLL patients in China have timely access to this global therapeutic innovation. We will fully leverage Innovent's leading brand presence and commercialisation capabilities in oncology, to accelerate the accessibility of this innovative therapy, thereby benefiting more cancer patients in need."