Ascentage Pharma announced today that the company's core product Orebatinib has obtained clinical trial approval from the Center for Drug Evaluation of the National Medical Products Administration (NMPA), and will conduct A pivotal registrational phase III study of combination chemotherapy versus imatinib plus chemotherapy in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). This means that Nelike® is expected to become the first tyrosine kinase inhibitor (TKI) drug for the first-line treatment of Ph+ ALL in China, which is a major milestone in the development of this product in this field .

Ph+ ALL accounts for about 20%-30% of adult ALL patients, and has the characteristics of high recurrence rate, short disease-free survival, and poor prognosis. Before the advent of small molecule targeted drug TKI, allogeneic hematopoietic stem cell transplantation (allo-HSCT) after chemotherapy was considered as the first-line treatment for patients with Ph+ ALL. It accounts for more than 70% of the total, and the 5-year overall survival rate is less than 30% [1] . The application of TKI has significantly changed the treatment prospects of Ph+ ALL, but the first-generation and second-generation TKI treatments have certain limitations, the recurrence rate is high, and the long-term survival rate is still not satisfactory. The 3-5 year overall survival rate is about 50% [ 2 ] , mainly related to its low complete molecular remission (CMR) rate and T315I kinase domain mutation, so there is still considerable room for improvement in the treatment of Ph+ ALL. At present, there is no TKI approved for the first-line treatment of Ph+ ALL patients in China. The use of more potent third-generation TKIs may further improve the prognosis of Ph+ ALL patients by inducing a higher CMR rate and inhibiting the T315I mutation.

Neriq® is an original Class 1 new drug of Ascentage Pharma, an oral third-generation TKI, and the first and only third-generation BCR-ABL inhibitor approved for marketing in China . Ascentage Pharma and Innovent Biologics are jointly responsible for the commercialization of Nelike® in China . Its indication for the treatment of adult patients with chronic myeloid leukemia (CML) in chronic phase (CP) or accelerated phase (AP) who are resistant to any TKI and associated with a T315I mutation has been approved by the National Medical Products Administration in November 2021. Approved by the Center for Evaluation (CDE). Previously, the drug was recommended by the CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies for the treatment of Ph+ ALL patients.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said: "The approval of this pivotal registration phase III study for newly diagnosed patients with Ph+ ALL is a major breakthrough for Neriq® in the field of Ph+ ALL. Standard treatment, but so far no TKI drug has been approved for first-line treatment. Neriq® is expected to become the first TKI drug for first-line treatment of Ph+ ALL. Adhering to the mission of 'solving the unmet clinical needs of patients in China and even the world', We will actively promote the clinical development of Nelike® in this indication, with a view to obtaining approval as soon as possible, so as to benefit patients.

 references

1. Fielding AK, Rowe JM, Richards SM, et a1. Prospective outcome data on 267 unselected adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia confirms superiority of allogeneic transplantation over chemo therapy in the pre imat inib era results from the International ALL Trim MRCUKALIXII/ECOG 2993 . Blood, 2009, 113: 4489- 4496.
2. Elias Jabbour et. Treatment of Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia-From Intensive Chemotherapy Combinations to Chemotherapy-Free Regimens: A Review. JAMA Oncol. 2022 Sep 1;8(9):1340-1348.

 

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