Athenex announced that target enrollment of 360 patients in the Oraxol Phase 3 clinical trial in metastatic breast cancer has been achieved on schedule. Athenex also reaffirms that top line data from the study is expected to be available in mid-2019.
Wednesday, January 9, 2019
Basilea: ‘positive’ interim results from Phase 2 study of derazantinib
ArQule’s partner, Basilea, announced results from the interim analysis of the registrational Phase 2 study with the orally administered pan-fibroblast growth factor receptor kinase inhibitor derazantinib. The analysis showed promising activity in patients with FGFR2 gene fusion-expressing intrahepatic cholangiocarcinoma and also confirmed the safety profile and tolerability of the drug candidate observed in previous clinical studies. The interim analysis in the ongoing registrational Phase 2 study was conducted after 42 patients had been enrolled in the study, with a subset of 29 evaluable patients who had at least one post-baseline imaging assessment. The objective response rate in the 29 evaluable patients was 21%. The disease control rate, reflecting the proportion of patients with a partial response or with stable disease, was 83%. The safety data obtained from all 42 patients enrolled to date was consistent with the results from previous clinical studies with derazantinib. ArQule COO Peter Lawrence said, “We are pleased with derazantinib’s continued progress since it was licensed to Basilea Pharmaceutica in April 2018 in the US, EU, Japan and rest of world excluding Greater China. Under the terms of the license agreement, ArQule is eligible to receive up to $326M in regulatory and commercial milestone payments, and we look forward to further progress and updates from Basilea.”
Herbalife ‘remains in good hands’ despite loss of CEO, says Pivotal Research
Pivotal Research analyst Timothy Ramey made no changes to his estimates or $62 price target on Herbalife Nutrition shares following news that CEO Rich Goudis was forced out of his position due to comments he made that the company said “were inconsistent with Herbalife Nutrition’s standards and do not reflect the company’s culture.” Ramey said Herbalife has “a strong management team with an excellent leadership group” and that he is “certain that the company remains in exceptionally strong hands.” He keeps a Buy rating on Herbalife shares, which are down about 2% to $57 in pre-market trading.
Zai Lab completes enrollment in niraparib Phase 3 trial
Zai Lab (ZLAB) announced completion of patient enrollment of its pivotal trial of niraparib, or Zejula in development for second-line maintenance therapy in patients with recurrent, platinum-sensitive ovarian cancer. The Phase 3 trial is evaluating niraparib as a second-line maintenance therapy in patients with recurrent platinum-sensitive ovarian cancer. Recurrent ovarian cancer patients who have responded to a platinum-containing regimen were enrolled in the study and randomized 2:1 to receive either niraparib or placebo once daily. Patients were stratified by gBRCA status. The primary endpoint is progression-free survival. The study enrolled its first patient in September 2017. Zai Lab in-licensed rights to Zejula from Tesaro (TSRO) for China, Hong Kong and Macau as an important, new treatment option to more than 50,000 Chinese patients who suffer from ovarian cancer every year. Zejula is positioned as a PARP inhibitor due to its efficacy, once-daily dosing and pharmacokinetic properties including its ability to cross the blood brain barrier. The NDA was accepted by the NMPA in December 2018. Zai Lab obtained approval for marketing Zejula in Hong Kong in October and launched the product in December 2018. Niraparib is also being evaluated in China in pivotal studies as first-line maintenance therapy in platinum-sensitive ovarian cancer and in small-cell lung cancer.
Akorn receives FDA warning letter related to Illinois manufacturing facility
https://thefly.com/landingPageNews.php?id=2846106
Seattle Genetics announces publication of data from ECHELON-1 Phase 3 trial
Seattle Genetics announced the publication of data from the ECHELON-1 phase 3 clinical trial online in the journal Clinical Cancer Research. The publication, titled “Brentuximab Vedotin Plus Chemotherapy in North American Patients with Newly Diagnosed Stage III or IV Hodgkin Lymphoma,” reports data from the North American patient population from ECHELON-1 evaluating ADCETRIS in combination with AVD in newly diagnosed stage III or IV classical Hodgkin lymphoma. These data were previously presented in a poster presentation at the 2018 American Society of Clinical Oncology Annual Meeting. In March 2018, the U.S. Food and Drug Administration approved ADCETRIS in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical HL based on the positive results of the ECHELON-1 phase 3 clinical trial. ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of classical HL that plays a role in tumor growth and survival. Of the 1,334 advanced stage classical HL patients who participated in the ECHELON-1 clinical trial, 497 patients were treated in North America, with 250 patients in the ADCETRIS plus AVD arm and 247 patients in the ABVD control arm. The manuscript presents the North American results which include: A pre-specified sensitivity analysis showed per Independent Review Facility (IRF) assessment, the two-year modified progression-free survival rate for patients in the ADCETRIS plus AVD arm was 84.3 percent compared to 73.7 percent in the control arm, which corresponds to a difference of 10.6 percent. On the ADCETRIS plus AVD arm, peripheral neuropathy events were observed in 80 percent of patients compared to 56 percent on the ABVD arm. In the ADCETRIS plus AVD arm, the majority of peripheral neuropathy events were Grade 1 or 2. Grade 3 events were reported in 17 percent of patients. In the ABVD arm, Grade 3 events were reported in less than one percent of patients. There were no Grade 4 events on either arm. Across both arms of the study, approximately 75 percent of the patients with peripheral neuropathy reported resolution or improvement at last follow-up. Febrile neutropenia during treatment was reported in 20 percent of patients in the ADCETRIS plus AVD arm compared with nine percent in the ABVD arm. In the ADCETRIS plus AVD arm, 14 percent received primary prophylactic G-CSF within five days of starting treatment and nine percent reported febrile neutropenia. Pulmonary toxicity was reported in three percent of patients in the ADCETRIS plus AVD arm versus ten percent of patients in the ABVD arm. Grade greater than or equal to3 events were reported in two percent versus six percent of patients, in the ADCETRIS plus AVD and ABVD arms, respectively.
Rafael Pharmaceuticals initiates CPI-613 Phase 2 trial
Rafael Pharmaceuticals announced the initiation of a phase 2 open-label trial in collaboration with University Hospitals Cleveland Medical Center to evaluate the efficacy and safety of investigational drug CPI-613 in combination with modified Folfirinox, or mFFX, in patients with localized borderline and unresectable pancreatic cancer. The primary objective of this study is to determine the potential increase in overall survival when CPI-613 is administered in combination with mFFX and to further assess the safety of the CPI-613+ mFFX combination. Pancreatic adenocarcinoma patients 19-80 years old of both sexes with ECOG performance status 0-1 are eligible for enrollment.
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