“Improvements in progression-free survival (PFS) with olaparib (Lynparza) over treatment of physician’s choice (TPC) remained consistent regardless of baseline tumor burden for patients with HER2-negative breast cancer with a germline BRCA1/2 mutation (gBRCA1/2m), according to an exploratory analysis from the phase III OlympiAD trial presented at the 2018 Miami Breast Cancer Conference (MBCC).
“Although not powered to show statistical significance between the groups, in those with one metastatic site (n = 71) the median PFS with olaparib was 8.4 months compared with 4.2 months with TPC (HR, 0.62; 95% CI, 0.35-1.13). In patients with ≥2 metastatic sites (n = 231), the median PFS was 6.5 months with olaparib compared with 3.0 months for TPC, which crossed the barrier for statistical significance (HR, 0.59; 95% CI, 0.43-0.82).”
“The progression-free survival (PFS) benefit for ribociclib (Kisqali) in pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer was sustained across patient subgroups, according to findings from the phase III MONALEESA-7 trial presented at the 2018 Miami Breast Cancer Conference.
“MONALEESA-7 randomized patients to either the CDK4/6 inhibitor ribociclib in combination with tamoxifen or a nonsteroidal aromatase inhibitor (NSAI; letrozole or anastrozole) plus goserelin (n = 335), or to endocrine treatment plus goserelin (n = 337). Across the overall study population, the median PFS was 23.8 months for the ribociclib arm compared with 13.0 months for the control arm (HR, 0.553; 95% CI, 0.441-0.694; P <.0001).”
“In the international phase III BRIM8 trial reported in The Lancet Oncology, Maio et al found inconclusive evidence of benefit of adjuvant vemurafenib treatment in patients with BRAF V600–mutant melanoma.”
“Trilaciclib appeared associated with reduced chemotherapy-induced myelosuppression and was well tolerated among patients undergoing first-line therapy for extensive-stage small cell lung cancer, according to results from a double-blind, placebo-controlled phase 2 trial.
“Findings from the phase III NETTER-1 trial led to the January 2018 FDA approval of Lutathera (lutetium Lu 177 dotatate) for the treatment of patients with somatostatin receptor–positive gastroenteropancreatic tumors (GEP-NETs). The trial compared Lutathera with high-dose octreotide LAR for patients with 1 or 2 metastatic midgut NETs.
“In NETTER-1, patients with midgut NETs who progressed on 30 mg of octreotide were randomized to Lutathera (n = 116) or high-dose octreotide (n = 113). Patients received 4 doses of Lutathera at 7.4 GBq every 8 weeks in combination with 30 mg of octreotide. The control arm received 60 mg of octreotide LAR every 4 weeks.”
“Re-engineering a common cold virus to attack the deadliest kind of brain tumor extended the survival of patients whose tumor returned after various treatments, including surgery, a Phase 1 clinical trial shows.
“While patients with glioblastoma usually live a median of six months, half were still alive at 9/12 months after receiving the re-engineered virus. And 20 percent lived for three years or longer.”
“Vemurafenib offered numerical improvement in disease-free survival in a study of patients with completely resected stage IIC to IIIC BRAF V600 mutation–positive melanoma, but the results did not reach statistical significance. The benefit was bigger in those with stage IIC to IIIB disease, but this should be considered exploratory at this point.
” ‘Despite full resection, patients with stage IIC to III melanoma remain at high risk for disease recurrence and death,’ wrote study authors led by Michele Maio, MD, of University Hospital of Siena in Italy. ‘This situation warrants the use of adjuvant approaches to improve clinical outcomes.’ ”
“The primary endpoint of improving overall survival (OS) was not met in the phase III JAVELIN Lung 200 Trial of avelumab (Bavencio) in patients with non–small cell lung cancer (NSCLC), according to Merck KGaA and Pfizer, the co-developers of avelumab.
“According to results of the study, the PD-L1 inhibitor did not improve OS for patients with PD-L1-positive (≥1%) unresectable, recurrent or metastatic NSCLC compared with docetaxel in patients who had progressed on platinum-containing doublet chemotherapy (hazard ratio [HR], 0.90; 96% CI, 0.72-1.12; one-sided P = .1627).”
“Recently reported updates from the KEYNOTE-189 and IMpower150 trials demonstrated the powerful impact of adding immunotherapy to treatment regimens for patients with non–small cell lung cancer (NSCLC).
“In the phase III KEYNOTE-189 study, the combination of pembrolizumab (Keytruda) with chemotherapy in the frontline setting improved survival in patients with nonsquamous NSCLC. In this trial, which is the confirmatory trial for the FDA approval of pembrolizumab plus carboplatin/pemetrexed, patients received frontline pembrolizumab or placebo combined with pemetrexed and either cisplatin or carboplatin. The study met the primary endpoints of improved overall survival (OS) and progression-free survival (PFS), though full data have yet to be presented.”