▎ WuXi AppTec content team editor
Recently, a broad-spectrum anti-tumor drug, Mitoxantrone Hydrochloride Liposome Injection (trade name: Doenda), was approved for marketing by the State Drug Administration of China (NMPA) for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
Screenshot source: NMPA official website
One of the common non-Hodgkin lymphomas
Lymphoma, also known as malignant lymphoma, is a group of malignant tumors that originate in the lymphoid hematopoietic system and are one of the common malignancies in China, which can be divided into Hodgkin lymphoma and non-Hodgkin lymphoma.
Peripheral T-cell lymphoma, a heterogeneous group of larger malignancies originating in mature T lymphocytes and NK cells in the posterior thymus, is a common subtype of non-Hodgkin lymphoma (NHL). In China, patients with peripheral T-cell lymphoma account for about 25%-30% of non-Hodgkin lymphoma, and most peripheral T-cell lymphomas have the characteristics of strong aggression, high malignancy and poor prognosis.
Peripheral T-cell lymphoma is common in middle-aged and elderly people, with a median age of onset of 55 years and no significant sex differences. After the disease, patients mostly present with superficial lymphadenopathy, half with B symptoms, including unexplained fever (>38 ° C), for more than 3 consecutive days, and is not caused by infection; night sweats (can soak clothing); weight loss, weight loss of 10% within half a year before diagnosis.
Peripheral T-cell lymphoma can also affect the skin and subcutaneous tissues, liver and spleen, digestive tract, thyroid and bone marrow, resulting in damage to related tissues or organs.
In addition, the prognosis of peripheral T-cell lymphoma is poor, and the Chinese Lymphoma Treatment Guidelines (2021 Edition) states that the 5-year survival rate of patients is about 30%.
Image credit: 123RF
Broad-spectrum antineoplastic drugs
Mitoxantrone hydrochloride liposome is a lipid preparation of mitoxantrone.
Mitoxantrone is a broad-spectrum antitumor drug with wide clinical application, but due to adverse reactions such as cardiotoxicity and bone marrow suppression, the clinical application of the drug has been limited. The pharmacokinetic behavior, tissue distribution, efficacy and toxicity of liposome dosage forms have undergone significant changes, and the efficacy and safety have increased significantly.
According to public information, the mitoxantrone hydrochloride liposome injection was approved for marketing in China this time, mainly based on the results of a key, single-arm, multi-center Phase 2 study.
The results of the study show that the liposome monotherapy of mitoxantrone hydrochloride has achieved good anti-tumor effects in the treatment of relapsed or refractory peripheral T cell lymphoma, as well as extranodal natural killer T cell lymphoma, which is expected to bring more lasting remission time and longer survival period for patients with peripheral T cell lymphoma; moreover, the good safety of the drug is also expected to bring better quality of life to patients.
Specifically, in terms of anti-tumor effects:
In patients with relapsed or refractory peripheral T-cell lymphoma, the objective response rate (ORR) was 41.7%, the complete response rate (CR) was 23.1%, the duration of remission (DoR) ratio at ≥3 months was 84.4%, and the longest median sustained response time was 19.45 months.
In terms of survival, patients with relapsed or refractory peripheral T-cell lymphoma had a progression-free survival (PFS) of 8.5 months, a median overall survival period was not reached, and the longest overall survival was 26.4 months (54 cases were still following up with overall survival), with an overall survival rate of 75% at 6 months and an overall survival rate of 68.2% at 9 months.
The monotherapy of mitoxraquinone hydrochloride liposome injection showed excellent antitumor effects in patients with immunoblastic lymphoma (AITL) subtype and extranoal nasal T-cell lymphoma (NKTCL) subtypes, with objective response rates of 64.0% and 42.9%, respectively.
In terms of security:
The adverse reactions of mitoxantrone hydrochloride liposome injection are mainly hematologic toxicity.
In terms of cardiotoxicity and non-hematologic toxicity of chemotherapeutic drugs, the incidence of mitoxantrone hydrochloride liposome injection was also significantly reduced.
Common adverse effects of liposome drugs, such as mucositis and hand-foot syndrome, also did not occur during follow-up treatment with mittoanthraquinone hydrochloride liposome injection.
In addition to the treatment of peripheral T-cell lymphoma, the treatment of solid tumors such as small cell lung cancer, liver cancer, breast cancer, and urinary epithelial cancer with mitoanthraquinone hydrochloride injection, as well as the treatment of hematological tumors such as acute myeloid leukemia, multiple myeloma, and diffuse large B-cell lymphoma, is also being explored.
We look forward to the approval of the marketing of mitoxraquinone hydrochloride liposome injection, which can bring new survival benefits and quality of life improvements to patients with peripheral T-cell lymphoma, and also hope that other studies of the drug will also proceed smoothly and achieve good results, bringing new treatment options to more patients as soon as possible."