Ovarian disease is a common female malignant tumor disease, and there are very large diagnosis and treatment requirements for its treatment plan at this stage. Recently, a new type of PARP retarder, Veliparib, has stepped into everyone's attention. This type of drug can treat various types of ovarian diseases, and can significantly improve the objective response rate (ORR) of patients. It is indeed a woman's ovarian disease. A great benefit for patients. Today we will discuss the efficacy and safety of Veliparib in the treatment of ovarian cancer in women.
Stephani Veliparib Drug Details
Stepani Veliparib is an oral PARP retarder developed by AbbVie. PARP is an endogenous enzyme in the body that repairs DNA damage in somatic cells. In addition to all normal somatic cells, PARP can also repair DNA damage in cancer stem cells and help cancer stem cells survive in the body. In addition, stepanib Veliparib can also improve the sensitivity of treatment of DNA damage, such as chemotherapy and radiotherapy (RT). When veliparib is used in combination with chemoradiotherapy and several cytotoxic drugs in different solid tumors, the actual effect is stronger than that with radiotherapy and chemotherapy alone. Previously, the PARP retarder Veliparib has already been assessed for orphan drug status by the UK FDA.
Stepani Veliparib experimental data information
1. Stepanib Veliparib monotherapy for ovarian disease: the objective response rate is 40%
The scientific study included 88 patients with onset of ovarian disease. Among them, 60 patients were BRCA1 or 2 gene mutations, and 28 patients were BRAC wild-type. The strongly recommended phase II dose (R2PD) is 400 Mg, and the objective response rate is 40% at the maximum tolerated dose (MTD), and the clinical benefit rate (CBR) for patients with BRCA gene mutations is 68%. Among BRCA WT patients, the objective response rate was only 4%, and the clinical benefit rate was 38%. The drug half-life of Veliparib is created at 5.2 hours. The most common adverse reactions were nausea and vomiting, fatigue and decreased reticulocytes.
2. Veliparib monotherapy for gBRCA gene mutation ovarian disease: the objective response rate is 35%
Phase II GOG280 study evaluating the efficacy of veliparib in the treatment of ovarian disease patients with germline-BRCA (gBRCA) mutations. The study included 50 cases of BRCA-mutated recurrent ovarian disease treated with Veliparib 400Mg twice a day, in which 60% were platinum-resistant and 72% had received two to three treatments.
The objective response rate was 26% in the overall population, 20% in platinum-resistant patients, and 35% in platinum-sensitive patients, with no statistical difference between the two groups. Negatively correlated progression-free survival (PFS) was 8.11 months (range 0.43-19.55 months) and negatively correlated overall survival (OS) was 19.7 months (range 2.3-19.7). The most common grade 2 toxicities were fatigue (26%), iron-deficiency anemia (14%), and gastrointestinal (nausea and nausea, 46% and 18%, respectively).
3. Stepanib Veliparib monotherapy for ovarian disease with unsuccessful multi-stage treatment: the objective response rate was 44%
The results of the phase I/II trial discussed the efficacy of veliparib in 45 patients with ovarian disease with gBRCA mutations who had been unsuccessful (median 4 lines of treatment) after multiple treatment sessions. The dosage of Veliparib is 300 mg twice a day. The results found that the objective response rate was 44%, the negative correlation response delay time was 7.6 months, the negative correlation progression-free survival time was 5.6 months, and the overall survival time was 13.7 months. obviously increase. It is important to note that the two patients were continuous reflectors and were treated again for three and four years respectively. The most common toxic side effects observed were iron deficiency anemia, fatigue, nausea and nausea. Compared with olaparib and rucaparib, veliparib had lower hematologic adverse effects (AEs) and was very similar to niraparib.
4. Stepanib Veliparib combined with carboplatin and gemcitabine, the objective response rate was 68.9%
The scientific study recruited 75 patients with unresectable or metastatic solid tumors, including 54 patients with ovarian disease, 67% of whom had gBRCA mutations. This patient did not receive more than 2 previous treatment regimens. The first day of Veliparib, carboplatin AUC4, the first day of the 8th day of gemcitabine 800Mg/m2, a course of treatment for 21 days, and then maintained the treatment with Veliparib.In terms of safety factor, the most common grade 3 and 4 AEs for veliparib were mononucleosis (56%) and thrombocytopenia (53%), and the overall toxicity profile was manageable. Among such patients, the progression-free survival of gBRCA-mutated patients was 8.6 months, and the objective response rate was 68.9%, while the progression-free survival of gBRCA-WT was 5.9 months, and the objective response rate was 42.8%.
A warm reminder for Hong Kong’s physical and mental health: Scientific research also emphasizes that the PARP retarder, Stepani, Veliparib, and cisplatin and gemcitabine can treat patients with BRCA gene mutation at the end-stage pancreatic tumor with a high efficiency of 77.8%. Veliparib and temozolomide have also carried out phase I clinical trials for the treatment of melanoma, breast cancer, ovarian disease and hepatocellular advanced liver cancer, etc., and they have shown very good effects. At this stage, Veliparib is in the clinical research phase, and everyone firmly believes that this drug can be approved for sale as soon as possible, benefiting a large number of patients with malignant tumors.
Original source: Laos No. 1 Pharmacy