Catch up with the latest developments in cancer research.
Catch up with the latest developments in cancer research.
Clovis Finishes Rociletinib NDA Submission
A new drug application has been submitted for rociletinib as a treatment for patients with EGFR T790M-positive metastatic non—small cell lung cancer following prior administration of an EGFR TKI. The NDA was based on data from the ongoing phase I/II TIGER-X trial, which was updated at the 2015 ASCO Annual Meeting. In patients with T790M-mutant NSCLC who received rociletinib at the recommended 500 mg dose (n = 48), the objective response rate was 60% and the disease control rate was 90%. A marketing authorization application has also been submitted to the European Medicines Agency for the same population, based on data from the TIGER-X trial. Both applications will be evaluated by the regulatory agencies before officially being accepted. These regulatory filings were preceded by a breakthrough therapy designation for the potent mutant-selective EGFR inhibitor in May 2014. In addition to the NDA, an application for premarket approval is anticipated for Qiagen’s therascreen EGFR RGQ PCR Kit as a companion diagnostic for rociletinib, according to the statement from Clovis. The therascreen EGFR test was initially approved in 2013 as a CDx for afatinib and recently received a new indication as a CDx for gefitinib. See more at http://www.onclive.com/web-exclusives/clovis-completes-rociletinib-nda-for-egfr-t790m-positive-nsclc
Lenvatinib Receives RCC Breakthrough Designation
On Tuesday last week, the FDA granted a breakthrough therapy designation to lenvatinib as a potential treatment for patients with advanced renal cell carcinoma who have received a VEGF-targeted therapy. The designation was based on findings from an open-label three-arm phase II study that demonstrated an improvement in progression-free survival for lenvatinib compared with everolimus in patients with advanced RCC. In findings presented at the 2015 ASCO Annual Meeting, lenvatinib monotherapy improved PFS by 39% versus everolimus monotherapy (HR = 0.61; P = .048). Additionally, the combination of lenvatinib and everolimus demonstrated a 60% improvement in PFS over everolimus alone (HR = 0.40; P <.001). The median PFS was 14.6 months for lenvatinib plus everolimus, 7.4 months for lenvatinib alone, and 5.5 months for everolimus. The ORR in the combination arm was 43%, with lenvatinib it was 27%, and with everolimus it was 6%. The median overall survival was 25.5 months in the combination arm, 19.1 months in the lenvatinib monotherapy arm, and 15.4 months in the single-agent everolimus arm. See more at http://www.onclive.com/web-exclusives/fda-grants-breakthrough-designation-to-lenvatinib-for-renal-cell-carcinoma#sthash.7JVSRut7.dpuf
Telotristat Etiprate Cuts Carcinoid Syndrome Diarrhea
Treatment with telotristat etiprate significantly reduced the average number of daily bowel movements compared with placebo for patients with carcinoid syndrome that was not adequately controlled by a somatostatin analog, according to top-line results from the phase III TELESTAR trial. In the trial, oral telotristat etiprate was administered at 250 mg and 500 mg 3 times daily with a somatostatin analog. Both doses were superior to placebo for the primary endpoint of reducing average daily bowel movements over a 12-week timeframe (P <.001). At baseline, the average daily bowel movements per patient were ≥4. In the 250 mg arm, treatment with telotristat etiprate demonstrated a 29% reduction in the average number of daily bowel movements at week 12 compared with baseline. In the 500 mg arm, there was a 35% reduction. Those in the placebo arm experienced a 17% reduction in average daily bowel movements. A greater than 30% reduction in daily bowel movements was experienced by 20% of patients in the placebo arm compared with 44% and 42% of those treated with telotristat etiprate in the 250 and 500 mg arms, respectively (P <.04). Full data from the trial are being submitted for presentation at an upcoming meeting. Additionally, Lexicon is working with the FDA to submit data from the TELESTAR trial for regulatory approval, according to the statement. See more at http://www.onclive.com/web-exclusives/telotristat-etiprate-reduces-carcinoid-syndrome-related-bowel-movement-frequency-in-phase-iii-study
EC Approves Neoadjuvant Pertuzumab Regimen
Last Friday, the European Commission approved the combination of pertuzumab, trastuzumab, and chemotherapy as a neoadjuvant therapy for adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer who are at high risk of recurrence. The decision was based on an improvement in pathological complete response with the pertuzumab triplet compared with other regimens in the phase II NeoSphere trial, marking the first approval based on this endpoint by the EC. In a 5-year analysis of the phase II study presented at the 2015 ASCO Annual meeting1 the pCR rate was 39.3% for the pertuzumab regimen compared with 21.5% with trastuzumab and chemotherapy alone (P = .0063). Additionally, the risk of disease progression or recurrence was reduced by 31% and 40%, respectively, with the addition of pertuzumab to trastuzumab and chemotherapy compared with trastuzumab and chemotherapy alone. In the United States, the combination was granted an accelerated approval by the FDA in September 2013 for patients at high risk for metastases or death with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer. This decision was based on an earlier assessment of the NeoSphere trial and TRYPHAENA study. See more at http://www.onclive.com/web-exclusives/neoadjuvant-pertuzumab-regimen-approved-in-europe-for-her2-positive-early-breast-cancer
Eribulin sNDA Submitted for Soft Tissue Sarcoma
An application has been submitted to the FDA for eribulin mesylate as a treatment for patients with soft tissue sarcoma following an anthracycline and at least one other regimen, based on an extension in overall survival with the microtubule dynamics inhibitor compared with dacarbazine in the phase III Study 309 trial. Findings from the open-label trial were presented at the 2015 ASCO Annual Meeting and represented the first phase III analysis to show an OS improvement for patients with soft tissue sarcoma. In the study, patients with intermediate- and high-grade leiomyosarcoma or adipocytic sarcoma experienced a median OS with eribulin of 13.5 months compared with 11.5 months for dacarbazine, representing a 23% reduction in the risk of death (HR = 0.768; P = .0169). The median OS in patients with the ADI subtype was 15.6 months with eribulin compared with 8.4 months with dacarbazine (HR = 0.511). In the LMS group, patients treated with eribulin had a median OS of 12.7 versus 13 months with dacarbazine (HR = 0.927). Regulatory filings have also been submitted to the European Medicines Agency and the Ministry of Health, Labour, and Welfare in Japan. The FDA will review the application within 60 days, at which point the agency will assign a review deadline under the Prescription Drug User Fee Act. See more at http://www.onclive.com/web-exclusives/regulatory-approval-sought-for-eribulin-in-soft-tissue-sarcoma