The China National Drug Administration (CNDA) has approved the first PARP inhibitor, Lipuzhuo (Olapali Tablet). Maintenance therapy for platinum-sensitive recurrent ovarian cancer. Since the government’s work report this year, almost every month, heavy tumor products have been approved. The approval of Olapali in China has once again confirmed the country’s determination and action to speed up the examination and approval of clinically needed new drugs and early benefit to domestic patients. .
Professor Martin of the Chinese Academy of Engineering and the director of the Gynecologic Oncology Society of the Chinese Medical Association said,”Ovarian cancer has been a major problem in the field of gynecological oncology for the past 30 years, and the five-year survival rate of patients has not improved. The first PARP inhibitor in China has been approved, and the treatment of ovarian cancer will enter the era of targeting. It is believed that the prognosis of patients with ovarian cancer in China will be significantly improved.”
The five-year survival rate is only 39 percent, and the domestic ovarian cancer diagnosis and treatment bottleneck needs to be broken.
In the past 10 years, the incidence of ovarian cancer in China has increased by 30 percent and the mortality rate has increased by 18 percent[1] . However, ovarian cancer has the lowest five-year survival rate in gynecologic malignancies, only 39 percent, and the highest recurrence rate in 5 years, reaching 70 percent. Due to the lack of effective screening methods and almost no specific symptoms, it is difficult to detect and diagnose early, so more than 70 percent of patients have been diagnosed at the time of diagnosis [2] .
Director of Department of Gynecologic Oncology, Chinese Academy of Medical Sciences, Deputy Director of Department of Surgery, Deputy Director of Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, and Professor Wu Lingying, Chairman of the Chinese Society of Clinical Oncology (CSCO) Gynecologic Oncology Expert Committee: “Lip Zhuo was approved in China Providing a therapeutic tool for doctors, providing a new therapeutic hope for ovarian cancer patients. A number of clinical trials have shown that Lippro (Olapali) has excellent clinical efficacy and significantly prolongs platinum-sensitive relapsing Progression-free survival in patients with ovarian cancer reduces the risk of disease progression and death in patients and improves the quality of life of patients.”
Unique “synthetic lethal” mechanism that significantly prolongs progression-free survival in patients with ovarian cancer
Lippo (Olapali) is the first oral poly ADP ribose polymerase (PARP) inhibitor that kills tumor cells by inhibiting PARP enzyme activity and preventing PARP and DNA dissociation, synergistically with DNA damage repair function defects . “Targeting block” The DNA repair pathway of tumor cells kills cancer cells from the “source.” At present, olalapril can be used for maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer, regardless of whether or not they carry BRCA mutations.
In the clinical study SOLO-2, BRCA germline mutations in platinum-sensitive recurrent ovarian cancer patients were treated with olalapril tablets (twice daily), PFS (no progression survival) was significantly extended to 19.1 months, and The side reaction is small [3], [4] . Study19 confirmed the efficacy of PARP inhibitors in platinum-sensitive recurrent ovarian cancer, with a nearly 2-fold increase in PFS ( progression-free survival) compared with placebo in the olapali group (8.4 in the olaapril group) Month VS placebo group 4.8 months), the risk of disease progression or death decreased by 65 percent[5] .
AstraZeneca and Merck have reached a strategic cooperation on cancer, and the two sides will jointly carry out clinical research and commercialization and promotion of innovative drugs such as Lipp. Mr. Wang Lei, Executive Vice President of AstraZeneca and President of International Business and China, said,“For patients with platinum-sensitive recurrent ovarian cancer, the first PARP inhibitor Lippro was approved as limited and unsatisfactory. These patients bring hope for survival. With the values of ‘scientific first, patient-centered’, in the future, AstraZeneca will not only bring more high-quality innovative drugs to patients, but also improve drug accessibility. We will continue to work hard and explore ways to reduce the economic burden of patients. We will also work together to promote the level of domestic gynecological cancer diagnosis and treatment.”
“The approval of Lippro (Olapali) once again demonstrates the Chinese government’s determination to accelerate the approval of innovative drugs and to make innovative drugs benefit Chinese patients,” said Joseph Romanelli, president of Merck China. “This time with Aspen The cooperation of Likang shows the long-term commitment of both of us in the field of gynecological oncology. In the future, we will work together to enable patients to benefit from Olapali and help the entire medical community to better understand the value of PARP inhibitors.”
AstraZeneca and Merck’s Oncology Strategic Cooperation
On July 27, 2017, AstraZeneca and Merck announced that they will reach a global strategic cooperation in the field of oncology, and both parties will jointly share the potential of AstraZeneca’s world’s first leading PARP inhibitor, Olapali, and its potential. The new drug MEK inhibitor selumetinib is clinically developed and commercialized for multiple tumor indications. This strategic collaboration is based on the growing scientific evidence that combination therapy of PARP and MEK inhibitors with PD-L1/PD-1 inhibitors can treat multiple types of tumors. Through cooperation, the two parties will jointly develop and commercialize the combination therapy of olapagli and selumetinib monotherapy and other potential drugs, and independently develop and commercialize olapagli and selumetinib with their respective companies PD-1/PD-L1. Combination therapy.
References
[1] Summary of 2013 Cancer Registration Work by the National Cancer Research and Research Office and the National Cancer Registry [2] NCCN Guidelines Version 1.2018 Ovarian Cancer [3] Ledermann JA. Ann Oncol. 2016 Apr;27 Suppl 1:i40-i44. [4] EMA. CHMP summary of positive opinion for Lynparza. 24/10/2014 [5] Study19 [6] Cancer Statistics in China, 2015 [7] EMA. CHMP summary of positive opinion for Lynparza. 24/10/2014(Sources: AstraZeneca; Merck)
Filed Under: Oncology
