“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the global phase III ALUR study showing that Alecensa® significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), who had progressed following treatment with platinum-based chemotherapy and crizotinib (hazard ratio [HR]=0.15, 95% CI: 0.08-0.29, p<0.001). Median PFS reported by the investigators, the primary endpoint of the study, was 9.6 months in patients who received Alecensa (95% CI: 6.9-12.2) compared with 1.4 months (95% CI: 1.3-1.6) in those who received chemotherapy. Median PFS assessed by an independent review committee (IRC), a secondary endpoint, was 7.1 months for patients who received Alecensa versus 1.6 months for patients who received chemotherapy (HR=0.32, 95% CI 0.17–0.59; p<0.001). The safety profile of Alecensa was consistent with that observed in previous studies and compared favourably to chemotherapy.”
“Even small tumours can be aggressive, according to a study in patients with early stage breast cancer that will be presented at the ESMO 2017 Congress in Madrid. Researchers found that nearly one in four small tumours were aggressive and patients benefited from chemotherapy. Aggressive tumours could be identified by a 70-gene signature.
” ‘Our results challenge the assumption that all small tumours are less serious and do not need adjuvant chemotherapy,’ said lead author Dr Konstantinos Tryfonidis, a researcher at the European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.”
“An analysis of two influential studies of prostate cancer screening concludes that the much-debated test “significantly” reduces deaths from the disease, suggesting that current recommendations against routine PSA screening might be steering men away from a lifesaving procedure.
“The analysis, published Monday in Annals of Internal Medicine, drew wildly different reactions, as is often the case with research on PSA screenings. Some experts in cancer screening and statistics said its novel approach was “on shaky ground” and used a “completely unverifiable” methodology that they had “never seen before,” but others praised its “intriguing and innovative approach.” There was one area of agreement, however: “I imagine it’s going to generate some buzz,” said biostatistician Ted Karrison of the University of Chicago.”
“Yesterday’s historic FDA approval of the first engineered T-cell treatment for cancer, Novartis’ Kymriah (tisagenlecleucel), was accompanied by inevitable questions about how the product would be priced. In the end, Novartis set the price at $475,000, which was lower than many analysts had predicted, considering the treatment is designed to cure some forms of acute lymphoblastic leukemia (ALL)—and in clinical trials it did just that for most patients.”
“Pembrolizumab (Keytruda) induced an overall response rate (ORR) of 33% in patients with extensive-stage small cell lung cancer (SCLC), according to findings from the open-label, phase Ib KEYNOTE-028 trial published in the Journal of Clinical Oncology.
“One patient (4.2%) experienced a complete response, 7 (29.2%) had partial responses, and 1 (4.2%) had stable disease for less than 6 months. Thirteen patients (54.2%) experienced disease progression as the best overall response.”
“Z-endoxifen, a potent derivative of the drug tamoxifen, could itself be a new treatment for the most common form of breast cancer in women with metastatic disease. This finding was reported from a clinical trial conducted by researchers at Mayo Clinic and the National Cancer Institute, and published in the Journal of Clinical Oncology.
“The final results of a first-in-human phase I study of Z-endoxifen in women with estrogen receptor positive metastatic breast cancer showed that the treatment was safe and resulted in tumor shrinkage in women whose tumors had progressed on standard anti-estrogen therapies, including tamoxifen.”
“The phase 3 study ACT IV showed that rindopepimut, an investigational vaccine against EGFRvIII, did not improve outcomes when added onto temozolomide (Temodar, Merck), the current standard of care. The combination of rindopepimut plus temozolomide provided a median survival of 20.0 months compared with 20.1 months for temozolomide alone in patients with newly diagnosed EGFRvIII glioblastoma and minimal residual disease (MRD) after surgical resection and adjuvant chemoradiation.
“The announcement that the trial results were negative was made some time ago, but full details of those results were published online August 22 in Lancet Oncology.”
“The FDA has accepted a resubmitted new drug application (NDA) for Lutathera (lutetium [177Lu] oxodotreotide) for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final approval decision on or before January 26, 2018.
“The NDA is based on the phase III NETTER-1 trial, which compared Lutathera with high-dose octreotide LAR for patients with grade 1 or 2 metastatic midgut NETs. In this trial, there was a 79% reduction in the risk of progression or death with Lutathera compared with octreotide.”
“The FDA granted breakthrough therapy designation to DS-8201 for the treatment of HER-2-positive locally advanced or metastatic breast cancer that progressed after treatment with other HER-2-targeting agents.
“The agency based the designation on preliminary evidence from a phase 1 study designed to evaluate the safety, tolerability and efficacy of DS-8201 (Daiichi Sankyo), an investigational HER-2-targeting antibody-drug conjugate.”