Date: 2014-09-27
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 2014 Congress of the European Society for Medical Oncology (ESMO)
Company: Abbvie (USA - IL)
Product: veliparib (ABT-888)
Action
mechanism: poly ADP ribose polymerase PARP inhibitor/PARP inhibitor. Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types. PARP is a naturally-occurring enzyme in the body that repairs damage to DNA, and in certain types of cancers, repairs cancer cells. Discovered by AbbVie researchers, veliparib is being developed to help prevent DNA repair in cancer cells and increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation.
Veliparib is currently being studied in more than a dozen cancers and tumor types, including Phase 3 studies in non-small cell lung cancer and breast cancer.
Disease: previously untreated metastatic or advanced non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On September 27, 2014, AbbVie released interim results from an ongoing Phase 2 study of veliparib in combination with chemotherapy, which showed a 35 percent improvement (P-value=0.14) in progression-free survival (PFS) and a 30 percent improvement (P-value=0.21) in overall survival (OS) in patients with previously untreated metastatic or advanced non-small cell lung cancer (NSCLC). These results, which evaluated veliparib as a potential treatment for metastatic or advanced NSCLC, were presented for the first time at the 2014 Annual Congress of the European Society for Medical Oncology (ESMO), September 26-30 in Madrid, Spain. Phase 2 Combination Trial in Patients with Non-Small Cell Lung Cancer (Abstract 1234): The Phase 2, randomized, double-blind trial was designed to evaluate the efficacy and safety of veliparib in combination with carboplatin and paclitaxel, two chemotherapeutic medicines. Patients in the squamous histology subgroup randomized to the veliparib arm demonstrated a PFS rate of 6.1 months compared to 4.1 months (HR=0.50; P-value=0.06) and an OS rate of 10.3 months compared to 8.4 months (HR= 0.71; P-value=0.22). Median PFS was improved from 4.2 to 5.8 months, and median OS was improved from 9.1 to 11.7 months. Common adverse events (?20% of patients) for the veliparib-containing arm included alopecia (39%), anemia (31%), neutropenia (36%), nausea (28%) and peripheral neuropathy (24%). Grade 3 and 4 adverse events (?10% of patients) included neutropenia (23%) and anemia (10%). AbbVie initiated a Phase 3 clinical trial evaluating veliparib in patients with squamous NSCLC earlier in 2014 to confirm the results of this Phase 2 study. Phase 1 Study in Japanese Patients with Non-Small Cell Lung Cancer (Abstract 1213): Also during ESMO, AbbVie presented data from a Phase 1 study evaluating veliparib in combination with carboplatin and paclitaxel in Japanese patients with NSCLC, which was designed to evaluate the preliminary efficacy of the treatment, as well as the recommended Phase 2 dose. The study demonstrated an overall response rate of 54.5 percent, with six patients achieving a partial response and four demonstrating stable disease ranging from 40 to 143 days. The study also demonstrated co-administration of carboplatin and paclitaxel had no significant effect on veliparib pharmacokinetics. Common treatment emergent adverse events (?20% of patients) were leukopenia (100%), neutropenia (100%), anemia (83.3%), thrombocytopenia (75%), increased aspartate aminotransferase (66.7%) and increased alanine aminotransferase (66.7%). Grade 3 or 4 adverse events occurring in more than two patients were neutropenia (12 patients), leukopenia (4 patients), anemia (3 patients) and hyponatremia (2 patients).
