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Clinical Trials Key to Expanding Novel Treatment Options in Metastatic CRC
December 22nd 2017Shubham Pant, MD, discusses therapeutic options for patients with metastatic CRC, while stressing the importance of clinical trials as an avenue to establish more novel treatment decisions in this setting.
Adjuvant Dabrafenib/Trametinib Granted Priority Review by FDA for BRAF+ Melanoma
December 22nd 2017Based on findings of the phase III COMBI-AD study, a supplemental new drug application for dabrafenib (Tafinlar) combined with trametinib (Mekinist) has been granted a priority review by the FDA as an adjuvant treatment for patients with <em>BRAF</em> V600E– or V600K–positive stage III melanoma following complete resection.
Novel Kinase Inhibitor Shows Encouraging Disease Control in Heavily Pretreated GIST
December 22nd 2017A novel kinase switch control inhibitor, DCC-2618, demonstrated an encouraging disease control rate (DCR) of 76% at 12 weeks in heavily pretreated patients with gastrointestinal stromal tumors (GIST) treated with a daily ≥100-mg dose, according to findings of a phase I first-in-human, dose-escalation trial.
Frontline Avelumab/Axitinib Combo Receives FDA's Breakthrough Designation for RCC
December 22nd 2017The PD-L1 inhibitor avelumab (Bavencio) has been granted a breakthrough therapy designation by the FDA for use in combination with the VEGF inhibitor axitinib (Inlyta) in treatment-naïve patients with advanced renal cell carcinoma.
Expert Weighs in On Recent Adjuvant Therapy Data in Melanoma
December 21st 2017For patients with high-risk melanoma, the area of adjuvant treatment has seen little progress until recently. In large part, this is due to the lack of consensus in the community on what treatments to use, when to use them, and in which patients to implement them, explains Michael B. Atkins, MD.
Apalutamide Granted FDA's Priority Review for Nonmetastatic CRPC
December 21st 2017Based on data from the phase III SPARTAN trial, apalutamide has been granted a priority review by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer, according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.
Adjuvant Pertuzumab Regimen Receives FDA Approval for HER2+ Breast Cancer
December 21st 2017Based on findings from the APHINITY trial, pertuzumab (Perjeta) has been approved by the FDA in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk for recurrence.
Expert Discusses Promising Results for Denosumab in Patients With Bone Tumors
December 20th 2017In a recent open-label phase II study, denosumab (Xgeva) demonstrated favorable results in patients with resectable giant cell tumor of bone (GCTB). More than one-third of the trial patients avoided surgery and nearly half had less morbidity with surgery when treated with denosumab.
Study Evaluating Several Drugs in Parallel for Newly Diagnosed Glioblastoma
December 20th 2017Several agents are being investigated for the treatment of patients with glioblastoma in an ongoing phase II clinical trial. Known as the INdividualized Screening Trial of Innovative Glioblastoma Therapy, the study will randomize patients to 1 of 4 arms—either the control arm of standard-of-care agent temozolomide, or 1 of 3 experimental arms.
Larotrectinib Demonstrates 93% Response Rate in Pediatric Patients With Solid Tumors
December 20th 2017According to findings from the phase I SCOUT trial, the novel pan-TRK inhibitor larotrectinib (LOXO-101) achieved a 93% response rate in pediatric patients with <em>TRK</em> fusion–positive solid tumors.
Ibrutinib Plus Chemoimmunotherapy Demonstrates Promising Frontline Results in CLL
December 19th 2017In patients with chronic lymphocytic leukemia (CLL), the addition of ibrutinib to standard frontline chemoimmunotherapy induced negative minimum residual disease (MRD) status in bone marrow for 83% of patients, according to results from a preliminary clinical study presented at the 2017 ASH Annual Meeting.
Selinexor Combo Induces 84% ORR in Relapsed/Refractory Myeloma
December 19th 2017Rapid and durable responses were induced with the combination of selinexor, weekly bortezomib (Velcade), and low-dose dexamethasone (Vd), according to results of a dose escalation/expansion trial of patients with relapsed/refractory multiple myeloma (RRMM) presented at the 2017 ASH Annual Meeting.
Frontline Osimertinib Granted FDA's Priority Review for NSCLC
December 19th 2017A supplemental new drug application (sNDA) for osimertinib (Tagrisso) has been granted a priority review by the FDA as a first-line treatment for patients with non–small cell lung cancer (NSCLC) whose tumors harbor <em>EGFR</em> mutations (exon 19 deletions or exon 21 [L858R] substitution mutations).
Olaparib/Durvalumab Combo Demonstrates 80% DCR in HR+/HER2- Breast Cancer
December 16th 2017According to phase II findings from the MEDIOLA trial presented at the 2017 San Antonio Breast Cancer Symposium, the combination of olaparib and durvalumab demonstrated a disease control rate of 80% for pretreated patients with germline <em>BRCA-</em>mutated, HER2-negative metastatic breast cancer, according to phase II findings from the MEDIOLA trial.
Abemaciclib/Pembrolizumab Combo Shows Signs of Activity in HR+/HER2- Breast Cancer
December 16th 2017According to early results from a pilot trial presented in a poster at the 2017 San Antonio Breast Cancer Symposium, the combination of abemaciclib and pembrolizumab showed preliminary signs of activity without additive toxicity for patients with pretreated HR-positive, HER2-negative metastatic breast cancer.
Kim Discusses Treatment Considerations for Patients With Pancreatic Cancer
December 16th 2017George P. Kim, MD, recently shared the treatment considerations and decisions he makes when treating patients with metastatic pancreatic cancer. Kim, a medical oncologist at 21st Century Oncology in Jacksonville, Florida, explained his treatment decisions based on 2 case scenarios during a <em>Targeted Oncology</em> live case-based peer perspectives dinner.
Nivolumab/Ipilimumab Combo Granted FDA's Priority Review for RCC
December 15th 2017Based on findings of the phase III CheckMate-214 trial, a supplemental biologics license application for the combination of nivolumab and ipilimumab has been granted a priority review by the FDA as a frontline treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma.
Blackwell Inaugurated as VP of Early Phase Development and Immuno-Oncology at Lilly
December 14th 2017Eli Lilly and Company has announced that Kimberly L. Blackwell, MD, a pioneer in breast cancer research, will serve as its vice president of early phase development and immuno-oncology. She will begin her new role on March 12, 2018.<br />
PALB2 Mutation Contributes to Risk of Developing Breast Cancer, But Not Ovarian
December 13th 2017According to research recently reported at the European Society of Gynaecological Oncology 2017 Congress, deleterious mutations in the PALB2 gene may account for development of breast cancer in women with an elevated risk due to a family history of breast or ovarian cancer, but who test negative for the BRCA1 or BRCA2 genes.
Pembrolizumab Receives FDA's Priority Review in PMBCL
December 12th 2017Pembrolizumab (Keytruda) has received a priority review from the FDA for a supplemental biologics license application (sBLA) for the treatment of adult and pediatric patients with relapsed/refractory primary mediastinal large B-cell lymphoma (PMBCL), according to a press release from Merck, the manufacturer of pembrolizumab. The findings were first presented at the 14th International Conference on Malignant Lymphoma and updated data were recently presented at the 2017 ASH Annual Meeting.
Expert Discusses Promise of CMB305 Immunotherapy Regimen in Sarcoma
December 9th 2017CMB305, an immunotherapy regimen that generates and expands anti–NY-ESO-1 T cells, demonstrated a favorable survival rate compared with other approved agents for recurrent soft tissue sarcoma, according to results presented at the 2017 ASCO Annual Meeting.