Arnold Pharma announces that Buparlisib (AN2025) for the treatment of recurrent or metastatic head and neck cancer has completed the first patient in the global phase III clinical trial | Yimai Meng broke the news

Recent popular reports from Yimaike ★ Following Merck, Arnold Medicine and Roche have joined hands! Co-exploring the combination of two of its products under development and PD-L1 monoclonal antibodyThe phase 1b clinical trial of the combination of Arnold Pharma AN0025 and Merck KEYTRUDA® completed the first patient dosing in the United States April 16, 2021 / Yimai Ke News eMedClub News/--Hangzhou, China and New Jersey, U.
S.
-Arnold Pharma, an innovative global biopharmaceutical company focused on tumor treatment, recently announced its oral PI3K inhibitor Buparlisib (AN2025) combined with paclitaxel for the treatment of relapse or metastasis The global multi-center phase III clinical trial (study name BURAN) of squamous cell carcinoma of the head and neck has successfully completed the first patient administration in Shanghai Oriental Hospital, China, opening the world's first PI3K drug in the field of head and neck cancer treatment.
Large-scale phase III clinical trials in multiple centers worldwide.

 The study is a randomized, open, multi-center phase III clinical study conducted globally to evaluate the efficacy and safety of Buparlisib combined with paclitaxel or paclitaxel alone in the treatment of recurrent or metastatic head and neck squamous cell carcinoma.

The main study endpoint is the patient's overall survival.

This study plans to recruit nearly 500 head and neck squamous cell carcinoma patients in more than 150 research centers in 15 major countries and regions in North America, Europe and Asia Pacific.
The enrollment criteria include those who have received PD-1/PD-L1.
Patients who have disease progression after monotherapy, PD-1/PD-L1 combined with platinum chemotherapy or received PD-1/PD-L1 treatment and platinum-containing chemotherapy (regardless of the order).

 The global incidence of head and neck squamous cell carcinoma ranks eighth among malignant tumors, and the mortality rate ranks twelfth, with approximately 840,000 new cases occurring each year1.

In recent years, although the emergence of immune checkpoint inhibitors has brought significant clinical benefits to patients with head and neck squamous cell carcinoma, its monotherapy or combined chemotherapy for the overall treatment of recurrent or metastatic head and neck squamous cell carcinoma The response rate is not high2.

For patients who do not respond or have disease progression after using immune checkpoint inhibitors, there are currently no other treatment options and the number of such patients is increasing year by year.

Therefore, there is an urgent need to explore more effective treatment methods to improve the overall survival benefits of patients.

 Professor Denis Soulières, a well-known expert in the field of global head and neck cancer research and the leader of the study, said: “The results of the previously completed global phase II clinical trial show that Buparlisib (AN2025) has good safety and effectiveness.
The goal is to provide patients who have progressed after immunotherapy or combined immunotherapy and platinum chemotherapy with a more effective treatment than paclitaxel.

" "Head and neck squamous cell carcinoma has made great breakthroughs in recent years.
However, there are still unmet needs for patients with recurrence or metastasis.

The study is expected to change the second-line treatment pattern of head and neck squamous cell carcinoma, and provide new treatment options for patients in China and around the world.

"Tongji University Affiliated Dongfang Professor Guo Ye, director of the first phase clinical trial center of the hospital and chairman of the Head and Neck Tumor Committee of the Chinese Society of Clinical Oncology, Professor Guo Ye pointed out, “As a doctor, I am pleased to see more and more researches being carried out in China and participating in them, and conducting trials in China.
It can accurately reflect the status of the Chinese population, accumulate more data and experience for clinical research, and promote the progress of head and neck cancer diagnosis and treatment in China.

" Dr.
Lars Birgerson, Chief Medical Officer of Arnold Pharma, said: “It is Arnold's responsibility to cooperate with the world's top researchers in clinical trials.
A very important part of the development strategy of pharmaceutical globalization.

We hope that Arnold's products can enter the market efficiently under such cooperation, so as to benefit more patients and families.

According to the results of the previously completed global phase II clinical trials It shows that the median survival time of patients after using Buparlisib (AN2025) is as high as 10.
4 months, and it has obtained the fast-track approval qualification granted by the US FDA.
The drug is expected to become the first PI3K inhibitor to be marketed in the field of head and neck cancer treatment, and it is a treatment belt for head and neck cancer.
Come to new ideas.About Head and Neck Squamous Cell Carcinoma The global incidence of head and neck squamous cell carcinoma ranks eighth among malignant tumors, accounting for about 90% of all head and neck cancers.
In
2020, the global incidence of head and neck squamous cell carcinoma Approximately 840,000, which is expected to rise to approximately 1 million by 2030.

Epidemiological data show that 50%-60% of patients with head and neck squamous cell carcinoma have developed locally advanced at the time of diagnosis, while 50%-60% of patients Recurrence will occur within two years.

Recurrent or metastatic head and neck squamous cell carcinoma usually has a poor prognosis and high mortality.

The emergence of immune checkpoint inhibitors has brought survival benefits to patients, but some patients have undergone PD-1/PD -L1 or PD-1/PD-L1 combined chemotherapy did not respond, and the proportion of this part is gradually increasing.

At present, there is no drug candidate that can meet the needs of such patients in the world to enter the registration clinical stage, and AN2025 is expected to become the world's first Related drugs
 on the market.
About the BURAN study The BURAN study is a randomized, open, multi-center phase III study, which aims to evaluate Buparlisib (AN2025) (once a day) in combination with paclitaxel (once a week) and paclitaxel alone (once a week) ) Efficacy and safety of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The
criteria for enrolling patients include having received PD-1/PD-L1 monotherapy, PD-1/PD-L1 combined use Patients with disease progression after platinum-based chemotherapy or sequential PD-1/PD-L1 treatment and platinum-based chemotherapy (regardless of the order).

 About Buparlisib (AN2025) Buparlisib (AN2025) is an oral pan-PI3K inhibitor For all PI3K subtypes of class I, it has shown anti-tumor activity in hematological malignancies and solid tumors.

In its global phase II clinical trial (BERIL-1) for the treatment of head and neck squamous cell carcinoma (HNSCC) , The patient’s median survival time is as high as 10.
4 months, and has been granted fast-track approval by the US FDA and approved to carry out phase III clinical trials. Currently, Buparlisib's global multi-center phase III clinical trial for HNSCC has started.

 About Arnold Pharma Arnold Pharma is a clinical-stage global biopharmaceutical company focusing on the development of innovative oncology drugs.
It has R&D and clinical operation centers in both China and the United States.

Arnold Pharma has built a global product pipeline through the model of "joint innovation" and "independent research and development", which currently covers more than 10 anti-tumor drug candidates.

Three of these drugs are currently in the clinical stage.
They are the AN2025 (Buparlisib) project that has obtained FDA fast-track qualifications, and are conducting global multi-center phase 3 clinical trials; those that also have FDA fast-track qualifications can be administered by intravenous injection.
The oncovirus AN1004 (Pelareorep) project has completed phase 2 clinical trials; the oral EP4 antagonist (AN0025) project, which is currently in early clinical development for a variety of solid tumors, is currently being tried with other treatment options (including radiotherapy and PD- 1/PD-L1 inhibitor therapy) combined use.

 Arnold Pharma has established a competitive management team and built a unique drug development technology platform.
At the same time, it has established strategic partnerships with many top pharmaceutical companies in the world.

Arnold Pharma is committed to becoming an innovative R&D company that creates "global new" oncology drugs, bringing more effective treatments to patients in China and even the world, and realizing the mission of turning cancer into a non-fatal disease and even curing.

For more information, please visit www.
adlainortye.
com.  References: 1.
Sung, H.
Ferlay, J.
Siegel, R.
Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries, 2021 Feb 4.
2.
Chen Xi, Qiao Mingzhe.
Immune checkpoint inhibitors Progress in the treatment of recurrent or metastatic head and neck squamous cell carcinoma.
Journal of Otolaryngology of Shandong University.
May 2019, Volume 33, Issue 3.
Statement: 1.
This indication has not been approved in China 2.
Arnold Medicine does not recommend Any unapproved medicine/indication use 3.
Only for medical and health professionals to communicate and use