“Adding a drug to a standard regimen for hormone receptor (HR)-positive and HER2-positive breast cancer improved progression-free survival, a researcher said here.
“In a Phase II randomized trial, investigators compared an aromatase inhibitor (AI) combined with pertuzumab (Perjeta) and trastuzumab (Herceptin) versus an AI just with trastuzumab in women with locally advanced or metastatic breast cancer, Grazia Arpino, MD, PhD, of the University of Naples Federico II in Italy, reported at a general session at the San Antonio Breast Cancer Symposium.
“The three-drug combination led to a median of 18.89 months without progression, compared with 15.8 months for the two drugs.”
“The addition of an aromatase inhibitor (AI) to pertuzumab (Perjeta) and trastuzumab (Herceptin) improved progression-free survival (PFS) by 3.09 months, when compared with trastuzumab plus an AI, according to findings from the phase II PERTAIN trial presented at the 2016 San Antonio Breast Cancer Symposium.
“In the ongoing, open-label study, the median PFS was 18.89 months with the pertuzumab combination compared with 15.80 months for trastuzumab and an AI alone. Furthermore, there was a 35% reduction in the risk of progression or death with the addition of pertuzumab (HR, 0.65; 95% CI, 0.48-0.89; P = .007).”
“A neoadjuvant regimen combining the CDK4/6 inhibitor abemaciclib with anastrozole induced a response rate of 54.7% in patients with HR+/HER2-negative early-stage breast cancer, according to findings from the phase II neoMONARCH trial presented at the 2016 San Antonio Breast Cancer Symposium.
“The study also met its primary endpoint of reduction in Ki67 expression level at week 2. The abemaciclib combination yielded a geometric mean change in Ki67 from baseline to day 15 of -92.6%.”
“GTx, Inc. (GTXI) announced today positive initial data from its ongoing open-label enobosarm Phase 2 clinical trial in women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. The pre-specified threshold for success of the trial was met early in the 9 mg cohort with 9 patients achieving a clinical benefit response at 24 weeks among the first 22 evaluable patients in that cohort, as reported by the Company on November 28, 2016. Clinical Benefit Response (CBR) is defined as a complete response (CR), partial response (PR) or stable disease (SD), as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks of treatment.”
“Progression-free survival was more than doubled for patients with metastatic hormone receptor (HR)-positive, HER2-negative breast cancer resistant to aromatase inhibitor therapy by adding everolimus (Afinitor) to treatment with the endocrine therapeutic fulvestrant (Faslodex), according to data from the PrECOG 0102 phase II clinical trial presented at the 2016 San Antonio Breast Cancer Symposium, held Dec. 6–10.
” ‘Endocrine therapy, often with an aromatase inhibitor, is the standard of care for most patients with HR-positive advanced breast cancer,’ said Noah S. Kornblum, MD, assistant professor of medicine at Albert Einstein College of Medicine and attending physician, medicine at Montefiore Einstein Center for Cancer Care. ‘However, over time, resistance to aromatase inhibitors develops and treating patients with aromatase inhibitor–resistant disease remains a challenge.’ ”
“G1 Therapeutics, Inc., a clinical-stage oncology company, announced today a clinical trial collaboration with Genentech, a member of the Roche Group. A Phase 2 clinical trial is expected to begin in the first half of 2017 and will evaluate the combination of Genentech’s immune checkpoint, anti-PD-L1 antibody Tecentriq® (atezolizumab) with G1’s CDK4/6 inhibitor trilaciclib (G1T28) as a first-line treatment for patients with small-cell lung cancer (SCLC) receiving chemotherapy.”
“GTx, Inc. (Nasdaq: GTXI) today announced that enobosarm achieved the pre-specified primary efficacy endpoint in the 9 mg dose cohort from patients in both stage 1 and the ongoing stage 2 of its Phase 2 clinical trial in women with advanced, estrogen receptor positive (ER+), androgen receptor positive (AR+) breast cancer. The primary efficacy endpoint requires at least nine patients (out of a total of 44 evaluable patients) to achieve clinical benefit, defined as either a complete response, partial response or stable disease, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks of treatment. In this ongoing trial, the efficacy endpoint was achieved in the first 22 confirmed evaluable patients, and the trial will continue enrolling and treating eligible patients with enobosarm until 44 evaluable patients have completed the trial. Enobosarm has been well tolerated among patients treated to date in the 9 mg dose cohort with the majority of adverse events being either grade 1 or 2.”
“Findings from a recent phase II study showed the PD-L1 inhibitor durvalumab generated durable responses in bevacizumab-naïve patients with recurrent glioblastoma multiforme (GBM). Findings of the study were presented at the 2016 Society for Neuro-Oncology Annual Meeting.
“In a 30-patient cohort, the 6-month progression-free survival (PFS) rate was 20.0% (6 patients; 90% CI, 9.7-33.0). The median PFS was 13.9 weeks (95% CI, 8.1-24.0). Of these 6 patients, 3 had wild-type IDH1 status and 3 had mutated IDH1.”
“Findings from a highly anticipated, randomized, phase II trial could possibly pave the path for the FDA approval of the first targeted therapy for patients with triple-negative breast cancer (TNBC), explains Linda T. Vahdat, MD.
“The METRIC study is exploring the efficacy and safety of glembatumumab vedotin (CDX-011) versus standard capecitabine in this subset of patients, particularly in those with high levels of glycoprotein NMB (gpNMB) expression (NCT01997333).
“The antibody-drug conjugate is a novel approach designed to target a very difficult-to-treat patient population, whose sole approved treatment option is standard chemotherapy, Vahdat stresses.”