The medium progression-free lifetime is extended by 4 times, and Olapali is again showing excellent efficacy.

Ovarian cancer is one of the most common malignant tumors in female reproductive organs, second only to cervical cancer and uterine malignancies, and the mortality rate is the highest in its kind.
worldwide, women with ovarian cancer are the eighth dead among all tumor-related female deaths, with 300,000 new diagnoses reported in 2018 and 185,000 deaths from ovarian cancer.
background, the development of ovarian cancer drugs has been the focus of major enterprises in the field, but also developed a series of drugs.
recently, Mercadon released five-year follow-up data for its Phase III clinical trial SOLO-1, which showed that late-stage BRCA after the new diagnosis had been fully or partially remissiond through platinum-containing chemotherapy. In maintenance therapy for patients with mutated ovarian cancer, Olaparib (LYNPARZA) significantly increases the patient's medium progression-free lifetime (mPFS) by up to four times as long as a placebo.
SOLO-1 Study SOLO-1 is a randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate Olapali's late-stage BRCA after achieving full or partial remission through first-line platinum-containing chemotherapy The safety and effectiveness of maintenance therapy in patients with mutated ovarian cancer were included in a group of 391 patients with harmful or suspected harmful reproductive system or soy cell BRCA1 or BRCA2 mutations who achieved complete or partial remission after receiving platinum-containing chemotherapy.
data show that compared to placebo Olapali, the risk of disease progression or death was reduced to 67% (HR 0.33 (95% CI 0.25-0.43) and the medium progression-free lifetime (mPFS) was increased to 56 months (13.8 months for placebo).
and within five years, 48.3 percent of patients treated with Olapali had no progression, while only 20.5 percent of patients in the placebo group had no progression.
Table 1. SOLO-1 study validity data is consistent with previously published data in terms of security data.
adverse reactions with an incidence greater than 20 per cent were nausea (77 per cent), fatigue/fatigue (63 per cent), vomiting (40 per cent), anemia (39 per cent) and diarrhoea (34 per cent). in the
Olapali group, 40 percent of patients reported adverse reactions greater than or equal to level 3, including anemia (22 percent) and neutral granulocyte reduction (9 percent);
In fact, the study reached its main research endpoint in June 2018 (i.e., the PFS evaluated by the researchers), based on previously disclosed data, including the FDA, EMA, NMPA, etc., which have approved their relevant listing applications and have been listed for sale in the countries concerned.
the five-year follow-up data disclosed this time is only further evidence of Olapali's good efficacy.
PARP inhibitor Olapali is a PARP inhibitor.
, known as Poly ADP-ribose Polymerase (PARP), is a DNA repair enzyme that plays a key role in the DNA repair path.
PARP is activated when DNA damage breaks, which, as a molecular receptor for DNA damage, has the function of identifying and binding to the location of DNA fracture, which activates and catalytics the polyADP ribosylation of receptor proteins and participates in the DNA repair process.
in addition to PARP, another type of protein in the body, BRCA (Breast Cancer Susceptibility Genes, a breast cancer susceptibility gene), also plays an important role in DNA repair.
the path is used to work with the PARP path, and when one of the paths fails and the DNA damage cannot be repaired, the damage is repaired by the other path.
Figure 1. According to statistics, about 22% of ovarian cancer patients carry BRCA1/2 mutations.
This means that for this group of patients, if their PARP path is inhibited, their DNA repair function will be inhibited, which will effectively inhibit the growth and proliferation of tumors in tumor cells that proliferate at a high rate in the body, dna damage that occurs during proliferation will not be repaired and will result in synthetic lethality.
PARP inhibitors are currently on the market worldwide, including Olaparib, listed on Chinese mainland, Niraparib, listed in Chinese mainland, Talazoparib, Rucaparib, and, according to incomplete statistics, there are still clinical stages of PARP inhibitors with 2X Oncology Developed 2X-121, Jeil Pharmaceutical's JPI-547, Theragnostics' THG-008, Ildong Pharmaceutical's IDX-1197, AbbVie's Veliparib, Yipai Pharmaceuticals' IMP-4297, Teva's CIP-9722, etc.
Table 2. PARP inhibitors And in China, is still in the clinical stage and the NDA stage of Baiji Shenzhou and Merck Sherano co-development of Pamiparib, Chenxin Pharmaceuticals and Shanghai Pharmaceutical Co., D.C. Mefuparib, Hengrui Pharmaceuticals fluorine Fluzoparib, TSL-1502, HWH-340, Qingfeng Pharmaceuticals and Shanghai Dino Pharmaceuticals developed SC-10914.
from the point of view of domestic enterprises, relative to Hengrui Pharmaceutical's fluorine Pali and Pamipali development progress in Baiji Shenzhou, the development of other PARP inhibitors in China have lagged behind.
In the "Fast-Follow" strategy occupies the mainstream of the domestic pharmaceutical industry, only the "fast" can be king, otherwise the hard-earned results will most likely be lost in a large number of original generic drugs and "me-too" class drugs difficult to shine, which is also a test of the drug companies in the early stage of the layout of the project.
conclusion At the patient level, the five-year follow-up data from the Olapali SOLO-1 study showed that ovarian cancer patients could indeed benefit from Olapali's treatment in the medium to long term, as evidenced by studies of other PARP inhibitors.
expect more PARP inhibitors to be available to give patients more choices while also delivering better outcomes.
Source: LYNPARZA® Improv Median Progress-Free Survival to Over Four and a Half Years Compared to 13.8 Months Place with Bo for Patients with BRCA-Mutated Advanced Ovarian Cancer 2011. doi: 10.1016/j.ccr.2011.01.047. CC BY 3.0. ClinicalTrials.gov, corporate.com.