“In a phase II trial reported in the Journal of Clinical Oncology, Szmulewitz et al found that low-dose abiraterone (Zytiga) given with a low-fat meal was noninferior to standard-dose abiraterone in the fasting state with regard to reduction in prostate-specific antigen (PSA) levels among patients with castration-resistant prostate cancer.”
“A combination of CMP-001, an intratumoral Toll-like receptor 9 (TLR9) agonist, and pembrolizumab (Keytruda), tested in patients with metastatic melanoma resistant to PD-1 checkpoint inhibition, was well tolerated and had clinical activity according to preliminary data presented from the ongoing phase Ib clinical trial at the AACR Annual Meeting 2018, April 14-18, in Chicago.
” ‘Checkpoint inhibition is quickly becoming a key tool for oncologists to treat cancer,’ said Mohammed Milhem, MBBS, clinical professor of internal medicine at the University of Iowa, Iowa City. ‘However, there are many patients that either initially respond to checkpoint inhibition and then progress, or never respond to this therapy to begin with. Finding safe and effective therapies for these patients is critical.’ ”
“Adding atezolizumab (Tecentriq) to chemotherapy and an angiogenesis inhibitor led to significant improvement in progression-free survival (PFS) for patients with untreated advanced nonsquamous non–small cell lung cancer (NSCLC), according to results from an ongoing trial presented at the 2018 AACR Annual Meeting.
“In the IMpower150 trial, patients who received the PD-L1 inhibitor along with bevacizumab (Avastin) and chemotherapy had a median PFS of 8.3 months compared with 6.8 months with bevacizumab and chemotherapy. The difference translated into a 38% reduction in the hazard for progression or death (HR, 0.62; 95% CI, 0.52-0.74; P <.0001).”
“Bristol-Myers Squibb Company (NYSE: BMY) today announced initial results from the pivotal Phase 3 study, CheckMate -227, evaluating the Opdivo (nivolumab) 3 mg/kg pluslow-dose Yervoy (ipilimumab, 1 mg/kg) combination in first-line advanced non-small cell lung cancer (NSCLC) patients with high tumor mutational burden (TMB) ≥10 mutations/megabase (mut/Mb). In the study, the combination demonstrated a superior benefit for the co-primary endpoint of progression-free survival (PFS) versus chemotherapy (HR 0.58; 97.5% CI: 0.41 to 0.81; p=0.0002). The PFS benefit was observed regardless of PD-L1 expression levels and in both squamous and non-squamous tumor histology. Additionally, based on an early descriptive analysis, encouraging overall survival was observed with the combination versus chemotherapy in patients with high TMB ≥10 mut/Mb (HR 0.79; 95% CI: 0.56 to 1.10).”
“Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from KEYNOTE-189, a pivotal Phase 3 trial evaluating KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and cisplatin or carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). Findings showed that the KEYTRUDA-pemetrexed-platinum chemotherapy combination significantly improved overall survival (OS), reducing the risk of death by half compared with chemotherapy alone (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001). In pre-specified exploratory analyses, an OS benefit was observed regardless of PD-L1 expression in the three PD-L1 categories that were evaluated, including: patients whose tumors were negative for PD-L1 (HR=0.59 [95% CI, 0.38-0.92]); patients whose tumors had PD-L1 tumor proportion scores (TPS) of 1-49 percent (HR=0.55 [95% CI, 0.34-0.90]); and patients who had a TPS of greater than or equal to 50 percent (HR=0.42 [95% CI, 0.26-0.68]). The addition of KEYTRUDA to pemetrexed plus platinum chemotherapy also achieved a significant improvement in progression-free survival (PFS), with a reduction in the risk of progression or death of nearly half for patients in the KEYTRUDA combination arm, compared with chemotherapy alone (HR=0.52 [95% CI, 0.43-0.64]; p<0.00001). A PFS improvement in the KEYTRUDA combination group was observed in patients whose tumors were negative for PD-L1 (HR=0.75 [95% CI, 0.53-1.05]); patients with a TPS of 1-49 percent (HR=0.55 [95% CI, 0.37-0.81]); and patients with a TPS greater than or equal to 50 percent (HR=0.36 [95% CI, 0.25-0.52]). These results are being presented today in a plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2018 (Abstract #CT075), with simultaneous publication in The New England Journal of Medicine.”
“The anti-PD1 immunotherapy nivolumab (Opdivo) given prior to surgical resection of stage 1-3 non-small cell lung cancer (NSCLC) was safe and resulted in major pathological responses in 45 percent of the patients, according to data from a clinical trial presented at the AACR Annual Meeting 2018, April 14-18.
“A major pathologic response is defined as 10 percent or fewer viable cancer cells detectable in the resected tumor following neoadjuvant treatment.”
“A few months ago, olaparib (Lynparza, AstraZeneca) was the first drug approved to treat women with advanced breast cancer with germline mutations in BRCA.
“That approval was based on a significant improvement in progression-free survival (PFS) compared with standard chemotherapy shown in the OlympiAD trial. The results led to quite some excitement among breast cancer researchers, as for example in the Medscape Oncologycommentary ‘OlympiAD: Olaparib Captures Gold for BRCA-Mutated Breast Cancer Patients.’
“Now, however, a final analysis of OlympiAD results shows that overall survival (OS) did not significantly improve.”
“The first-ever direct comparison of three adjuvant aromatase inhibitors for the treatment of postmenopausal hormone receptor–positive early breast cancer shows no significant differences in clinical efficacy or safety, according to an Italian research team.
“In the randomized, open-label phase 3 FATA-GIM3 trial of almost 3700 women, the 5-year disease-free survival for patients treated with anastrozole (Arimidex, Novartis), exemestane (Aromasin, Pfizer), or letrozole (Femara, Novartis) was 90.0%, 88.0% and 89.4%, respectively.”
“Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-042 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary endpoint of overall survival (OS). An interim analysis conducted by the independent Data Monitoring Committee (DMC) demonstrated that treatment with KEYTRUDA resulted in significantly longer OS than platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed) in patients with a PD-L1 tumor proportion score (TPS) of ≥1 percent. As part of a pre-specified analysis plan, OS was sequentially tested and was significantly improved in patients with a TPS of ≥50 percent, with a TPS of ≥20 percent and then in the entire study population with a TPS of ≥1 percent. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported monotherapy studies involving patients with advanced NSCLC.”