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In November 2022, China's first new-generation highly selective PI3Kδ inhibitor, Linplisept (trade name: Intari), ® was officially approved by the National Medical Products Administration (NMPA) of China for the treatment of patients
with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two previous systemic therapies.
On January 6, 2023, Professor Ma Jun of Harbin Institute of Hematology and Oncology and Professor Wu Depei of the First Affiliated Hospital of Soochow University prescribed the first batch of prescriptions for Linplisset, marking the official entry of Intari ® into clinical application and bringing a new treatment option to R/R FL patients in China!
The blade was unsheathed, and the first prescriptions of Linplisse landed nationwide
After nearly ten years of research and development, Linplisse, a highly selective PI3Kδ inhibitor of China's innovative drug, has been officially approved
in November 2022.
On January 6, 2023, Professor Ma Jun and Professor Wu Depei prescribed Linplisset for the first batch of patients with R/R FL, and the first new generation of PI3Kδ inhibitors independently developed by patients in China officially entered clinical application, opening the way of real-world exploration, providing breakthrough treatment options for patients with R/R FL, and having positive significance
for solving the clinical drug choice of patients with R/R FL IN CHINA.
Figure 1 Professor Ma Jun and Professor Wu Depei prescribed the first batch of Linplisset
At present, Linplisac has been included in the catalogue of Huimin Insurance in the Guangdong-Hong Kong-Macao Greater Bay Area, and other cities are actively applying, further improving drug access, reducing the economic burden of patients, benefiting more Chinese lymphoma patients, and bringing patients a longer hope of survival!
It is expected that Linplisac will benefit more patients
Professor Ma Jun: As one of the common malignant tumors in China, lymphoma still has a large number of unmet clinical needs
.
In the past, we often looked forward to the introduction
of leading drugs overseas.
Nowadays, China's independent innovative drugs have entered the sight of patients and doctors with a breakthrough trend
.
The highly selective PI3Kδ inhibitor Linplisset officially entered the clinic as an innovative drug independently developed in China, providing patients with a breakthrough treatment option
.
Safety is the cornerstone
of treatment continuity and efficacy.
Linplisset was safe and controllable, and data from 322 large Chinese groups confirmed its good tolerability, reduced two black-box warnings compared with similar drugs, and significantly improved common serious gastrointestinal side effects and hepatotoxicity, with a low incidence of hyperglycemia and no adverse effects
of hypertension.
"Life first, life above all" is the mission and goal of doctors, in the future, we will continue to work hand in hand with national enterprises to bring hope to lymphoma patients in China and even the world
.
Professor Wu Depei: The pathological types of lymphoma are complex, the treatment principles are different, and the emergence of new drugs has improved the prognosis
of patients.
However, for patients such as FL, survival time is significantly shortened
with the increase in the number of disease recurrences.
New choices, therefore, may represent new hope
.
With a number of effective and safe clinical studies and unique drug mechanisms, Linplisset was approved by NMPA and officially put into clinical use, leading the development of PI3K inhibitors into a new era
.
The Hematology Branch of the Chinese Medical Association is willing to walk with Linpliser and work hard
for the remission of FL patients in China.
Linpliser is currently actively exploring the treatment of other lymphoma subtypes such as peripheral T-cell lymphoma (PTCL) and diffuse large B-cell lymphoma (DLBCL), and has achieved preliminary and surprising results, I believe that Linplisset, as a new generation of PI3Kδ inhibitors, is expected to make up for the current treatment gap of non-Hodgkin lymphoma such as PTCL and DLBCL, and look forward to bringing clinical cure to more patients with hematological tumors!
Based on the current situation, FL treatment is urgently needed, and effective and safe treatment drugs are urgently needed
FL is a common indolent non-Hodgkin lymphoma
originating from follicular center B cells.
Immunochemotherapy is currently the most commonly chosen FL treatment mode at home and abroad, and in recent years, the emergence of new drugs such as monoclonal antibodies and immunomodulators has improved the survival and prognosis of FL patients1
.
However, except for a very small number of patients with very limited lesions who are expected to be cured by radiotherapy ± chemotherapy, the vast majority of patients are difficult to cure2, and with the increase of the number of treatment lines received by FL patients, their overall survival (OS) and progression-free survival (PFS) are significantly reduced, and after first-line to six-line therapy, the median OS is NR, 11.
7 years, 8.
8 years, 5.
3 years, respectively, 3.
1 years and 1.
9 years; PFS: NR, 1.
5 years, 1.
1 years, 0.
9 years, 0.
6 years, and 0.
5 years (Figure 2)3
.
Therefore, there is an urgent need for effective and safe therapeutic drugs to induce deep and durable remission and improve patient survival and prognosis
.
Figure 2.
OS and PFS results based on the number of treatment lines in 922 FL patients
Facing the difficulties, Limpliser broke the FL recurrence/refractory dilemma
The PI3K signaling pathway is involved in physiological activities such as cell growth, proliferation, differentiation, motility, survival and intracellular transport, and has important physiological significance for the maintenance of normal cell function4
.
As a PI3Kδ inhibitor, Linplisset can reduce the level of AKT phosphorylation and induce apoptosis of tumor cells; It can also enter tumor cells, regulate the tumor immune microenvironment, play a synergistic role in the apoptosis of tumor cells, and jointly exert anti-tumor effects
.
In addition, Linplisept accurately inhibits PI3K δ kinase, which is more helpful to reduce adverse reactions such as hyperglycemia, hypertension and anemia that are prone to occur due to inhibition of other subunits, and is safer5,6
.
Figure 3.
Mechanism of action of Linplisset
The 2022 EHA Annual Meeting released the latest data from the Chinese phase II clinical trial of Linplisset for the treatment of patients with R/R FL.
7 Including patients with R/R FL who had received at least 2 sessions of systemic therapy, receiving oral Limplisept 80 mg once daily, the results showed that the total response rate (ORR) of patients was 79.
8%, The disease control rate (DCR) was as high as 96.
6%, and the 12-month OS rate was 91.
4%; The drug had a rapid onset of action, with a median remission time of 1.
9 months, a median PFS of 13.
4 months, and a median duration of response (DOR) of 12.
3 months.
Professor Ma Jun
Director of Harbin Institute of Hematology and Oncology, Chief Physician, Professor, Doctoral Supervisor
Chairman of the Supervisory Board of the Chinese Society of Clinical Oncology (CSCO).
Vice Chairman of the Asian Society of Clinical Oncology
Chairman of the Leukemia Expert Committee of the Chinese Society of Clinical Oncology
Leader of the expert group of the lymphoma specialty construction project of the Capacity Building and Continuing Education Center of the National Health Commission
Honorary consultant of the Nursing Group of the Lymphoma Expert Committee of the Chinese Society of Clinical Oncology
In 1979, he went to Japan to study at the University of Tokyo School of Medicine, and has been committed to the diagnosis and treatment of benign and malignant diseases of the blood system, especially for the treatment of leukemia and lymphoma
.
In 1982, the first in vitro pluripotent hematopoietic progenitor cell culture system was established in China to fill the domestic gap
.
Since 1983, more than 1200 cases of acute promyelocytic leukemia have been treated with retinoic acid and arsenic trioxide sequential therapy, and the 10-year disease-free survival rate has reached the international advanced levelHe has published more than 200 papers and more than 40 monographs in domestic and foreign journals, and won 20 national, provincial and municipal science and technology awards
It has undertaken 8 national 863 major scientific research projects and 25 provincial and municipal scientific research projects
Professor Wu Depei
Chief physician, professor, doctoral supervisor
Director of the Department of Hematology, The First Affiliated Hospital of Soochow University
Executive Deputy Director of the National Clinical Research Center for Blood System Diseases
Deputy Director of Jiangsu Institute of Hematology
Director of the Institute of Hematopoietic Stem Cell Transplantation, Soochow University
Member of the 13th National Committee of the Chinese People's Political Consultative Conference
Chairman of the Hematology Branch of the Chinese Medical Association
Vice President of Hematologist Branch of Chinese Medical Doctor Association
Vice Chairman of the Expert Committee of China Hematopoietic Stem Cell Donor Database
Editor-in-Chief of the Chinese Journal of Hematology
References:
[1] Cheah CY, et al.
Best Pract Res Clin Haematol.
2018 Mar; 31(1):41-48.
[2] Chinese Society of Clinical Oncology Guidelines Working Committee.
Guidelines for the diagnosis and treatment of malignant hematological diseases of the Chinese Society of Clinical Oncology (CSCO) 2022[M].
Beijing: People's Medical Publishing House, 2022.
[3] Batlevi CL, et al.
Follicular lymphoma in the modern era: survival, treatment outcomes, and identification of high-risk subgroups.
Blood Cancer J.
2020; 10(7):74.
Published 2020 Jul 17.
[4] Ersahin, T, et al.
(2015).
The PI3K/AKT/mTOR interactive pathway.
Molecular bioSystems, 11(7), 1946–1954.
[5] Vanhaesebroeck, B.
, Perry, M.
, Brown, J.
R.
, André, F.
, & Okkenhaug, K.
(2021).
PI3K inhibitors are finally coming of age.
Nature reviews.
Drug discovery, 20(10), 741–769.
[6] Mishra, R.
, Patel, H.
, Alanazi, S.
, Kilroy, M.
K.
, & Garrett, J.
T.
(2021).
PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects.
International journal of molecular sciences, 22(7), 3464.
[7] Lugui Qiu et al.
2022EHA.
Abstract 1119
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