Adding ADT to RT Improved PFS After Radical Prostatectomy

“Assigning men in biological relapse after radical prostatectomy to combined salvage treatment with hormone therapy and radiation therapy significantly delayed disease progression compared with radiation therapy alone, according to the results of the GETUG-AFU 16 phase III trial (abstract 5006).

“ ‘Salvage radiotherapy combined with limited androgen deprivation therapy improves the 5-year progression-free survival rate compared to radiotherapy alone,’ said study presenter Christian Carrie, MD, of the department of radiation oncology at the University of Lyon-Centre Leon Berard. ‘There is no significant difference in overall survival, but the follow-up is still too short.’

“Between October 2006 and March 2010, 743 patients were enrolled in GETUG-AFU 16 and randomly assigned to radiation therapy alone (n = 374) or radiation plus hormone therapy with goserelin 10.8 mg for 6 months (n = 369). The primary endpoint of the trial was progression-free survival.”


Immunomedics Reports Complete Responses in Patients With Metastatic Triple-Negative Breast Cancer After Sacituzumab Govitecan Treatment

“Immunomedics, Inc., (IMMU) today announced that among 49 patients with metastatic triple-negative breast cancer (TNBC) evaluated for response to treatments with sacituzumab govitecan in a mid-stage clinical study, 31%, or 15 patients, showed a reduction in tumor size of 30% or more. They include 2 patients with complete response. Response assessments were based on the rules set by the Response Evaluation Criteria In Solid Tumors (RECIST 1.1). Adding the 22 patients with responses between less than 30% tumor shrinkage and less than 20% tumor increase, the disease control rate was 76%.

“Sacituzumab govitecan also produced significant duration of response in these responding patients. Measured as the time it takes from the beginning of sacituzumab govitecan treatments to when the cancer progresses, the median progression-free survival (PFS) for the 48 patients who received the optimal doses of 8 or 10 mg/kg was 6.0 months. Importantly, 63% of patients (22 of 35) had a time-to-progression longer than their last therapy, notwithstanding disease progression has not yet happened in 56% of patients at the time of analysis.

“These results were presented at the 2015 Annual Meeting of the American Society of Clinical Oncology by Dr. Aditya Bardia of Massachusetts General Hospital Cancer Center in Boston, MA, and a faculty member at Harvard Medical School, who commented, ‘Given that a majority of the patients enrolled into this study had failed 4 or more prior cancer therapies, some as many as 11, we are quite encouraged with sacituzumab govitecan in this late-stage setting in an aggressive disease that is difficult to treat.’ “


AbbVie Presents Phase 2 Results from Study of Investigational Medicine Veliparib in Patients with Non-Small Cell Lung Cancer at the American Society of Clinical Oncology Annual Meeting

“AbbVie (ABBV), a global biopharmaceutical company, today announced findings from a Phase 2 study of the investigational medicine veliparib combined with the chemotherapy regimen carboplatin and paclitaxel that showed an improvement in median progression-free survival (PFS) in patients with previously untreated metastatic or advanced non-small cell lung cancer (NSCLC) who are current smokers. These data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1 in Chicago. Veliparib is an investigational oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor being evaluated for the treatment of various cancer types, including NSCLC.

” ‘The results from this study support further evaluation of this investigational regimen in advanced stage NSCLC patients with smoking history,’ said Suresh S. Ramalingam, M.D., professor of hematology and medical oncology, Emory University. ‘Veliparib showed interesting results when combined with chemotherapy in a subset of patients with smoking history.’ “


Exelixis Announces Positive Results from Phase 2 Trial of Cabozantinib in Patients with EGFR Wild-Type Non-Small Cell Lung Cancer

“Exelixis, Inc. EXEL, +9.21% today announced positive results from a phase 2 clinical study evaluating cabozantinib as a treatment for EGFR wild-type non-small cell lung cancer (NSCLC). The trial, Study E1512, is a randomized phase 2 trial by the ECOG-ACRIN Cancer Research Group of cabozantinib and erlotinib, alone or in combination, as second- or third-line therapy in patients with metastatic EGFR wild-type NSCLC. Exelixis previously announced positive top-line results from this trial in November 2014. Data from the trial will be presented today during an oral presentation (Abstract #8003) at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held this week in Chicago, Illinois. Study chair Joel Neal, M.D., Ph.D., of ECOG-ACRIN’s Thoracic Cancer Committee and an Assistant Professor of Medicine (Oncology) at Stanford University/Stanford Cancer Institute will present the results.

“Study E1512 met its primary endpoint, demonstrating significant increases in progression-free survival (PFS) for cabozantinib and the combination of cabozantinib plus erlotinib when individually compared to the erlotinib arm. The median PFS for the combination of cabozantinib and erlotinib was 4.7 months versus 1.9 months for erlotinib alone, a more than two-fold increase that corresponds to a 65% reduction in the risk of disease worsening (hazard ratio [HR]=0.35, 80% CI 0.23-0.52, p=0.0005). The median PFS for cabozantinib monotherapy was 4.2 months versus 1.9 months for erlotinib alone, a more than doubling that corresponds to a 62% reduction in the risk of disease worsening (HR=0.38, 80% CI 0.27-0.55, p=0.0004).”


Pivotal Results from Phase III Trial Show Combination of Ipilimumab and Nivolumab or Nivolumab Alone Increase Progression-Free Survival in Advanced Melanoma Patients

“Treating advanced melanoma patients with either a combination of the immunotherapy drugs nivolumab (Opdivo™) and ipilimumab (Yervoy™) or nivolumab alone significantly increases progression-free survival (PFS) over using ipilimumab alone, according to new findings from researchers at Memorial Sloan Kettering Cancer Center (MSK) simultaneously presented today at the American Society of Clinical Oncology (ASCO) annual meeting and published online in the New England Journal of Medicine (NEJM). Examining specific characteristics of each patient’s tumor has also given researchers clearer understanding of which patients should receive the combination.

“These initial findings from the phase III clinical trial confirm the results of the phase II trial, presented just weeks ago at the American Association of Cancer Research annual meeting in Philadelphia and published by MSK researchers online in NEJM.”


Cobimetinib and Vemurafenib Combination Treatment Is Highly Active in BRAF+ Melanoma

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced follow-up data from two studies of the investigational MEK inhibitor cobimetinib in combination with Zelboraf® (vemurafenib). Updated data from the pivotal coBRIM Phase III study showed the combination helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live a median of one year (12.3 months) without their disease worsening or death (progression-free survival; PFS) compared to 7.2 months with Zelboraf alone (hazard ratio [HR]=0.58, 95 percent confidence interval [CI] 0.46-0.72).1

“ ‘The combination of cobimetinib and Zelboraf extended the time people lived without their disease getting worse to a year,’ said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. ‘These results are exciting because they underscore the importance of combining medicines that target the signals, which cause about half of all melanomas to grow.’ “


Meta-Analysis Shows Increased Benefit of EGFR Tyrosine Kinase Inhibitors vs Chemotherapy in Subgroups of Patients With EGFR-Mutant NSCLC

“In a meta-analysis reported in the Journal of Clinical Oncology, Lee et al found that increased progression-free survival benefit of EGFR tyrosine kinase inhibitor treatment vs chemotherapy was exhibited in patients with exon 19 deletion, never-smokers, and women.

“The meta-analysis included seven trials (N = 1,649) comparing EGFR tyrosine kinase inhibitors with chemotherapy in patients with newly diagnosed advanced EGFR-mutant disease. Overall, tyrosine kinase inhibitor therapy was associated with significantly prolonged progression-free survival (hazard ratio [HR] = 0.37, 95% confidence interval [CI] = 0.32–0.42)…

“The investigators concluded: ‘Although EGFR [tyrosine kinase inhibitors] significantly prolonged [progression-free survival] overall and in all subgroups, compared with chemotherapy, greater benefits were observed in those with exon 19 deletions, never-smokers, and women. These findings should enhance drug development and economic analyses, as well as the design and interpretation of clinical trials.’ “


Enzalutamide Extends PFS in Castration-Resistant Prostate Cancer

“Patients with castration-resistant prostate cancer treated with enzalutamide demonstrated significantly longer PFS than those treated with bicalutamide, according to topline results of the phase 2 STRIVE trial released by Astellas.

“The trial included 396 patients with castration-resistant prostate cancer. About two-thirds of the patients (n = 257; 64.8%) had metastatic disease. The other 139 patients had nonmetastatic disease that progressed after surgical castration or treatment with a luteinizing hormone-releasing hormone analogue therapy.

“Researchers randomly assigned patients to 160 mg once-daily enzalutamide (Xtandi; Astellas, Medivation) — an androgen receptor antagonist — or 50 mg once-daily bicalutamide, an oral non-steroidal antiandrogen. PFS served as the primary endpoint.

“Patients assigned enzalutamide demonstrated a significant improvement in median PFS (19.4 months vs. 5.7 months; HR = 0.24; 95% CI, 0.18-0.32), according to a press release issued by Astellas. Median time on treatment also was longer in the enzalutamide group (14.7 months vs. 8.4 months).”


Maintenance Sunitinib Improved PFS in Extensive-Stage SCLC

“The use of maintenance sunitinib improved progression-free survival (PFS) over placebo among patients with untreated extensive-stage small-cell lung cancer (SCLC) in a new phase II study.

“ ‘Most of the 30,000 patients newly diagnosed each year with SCLC in the United States have extensive-stage disease,’ wrote study authors led by Neal E. Ready, MD, PhD, of Duke University Medical Center in Durham, North Carolina. ‘Despite achieving good disease control initially, patients with SCLC usually experience relapse within 6 months of first-line chemotherapy and often do not respond to subsequent chemotherapy.’

“In previous studies, maintenance chemotherapy after standard platinum-based therapy did not show any overall survival benefit. The new study aimed to test whether sunitinib, a small-molecule tyrosine kinase inhibitor that inhibits VEGF receptors and other targets. Results of the new study were published online ahead of print in the Journal of Clinical Oncology.

“The study enrolled a total of 144 patients, 49 of whom progressed or did not complete induction chemotherapy; 95 patients were randomly assigned to a placebo maintenance therapy group (46 patients) or a sunitinib maintenance therapy group (49 patients), and five patients on each arm did not receive the maintenance therapy. Sunitinib patients received 37.5 mg per day until progression.”