A phase III trial is being initiated to evaluate the combination of regorafenib and nivolumab in comparison with regorafenib alone in patients with microsatellite stable metastatic colorectal cancer.
Lisa Astor
Lisa Astor is the Associate Editorial Director for Targeted Oncology. Astor received her Bachelor of Arts in English Literature from New York University.
Articles by Lisa Astor
Novel agent namodenoson demonstrated tolerability in a favorable safety profile in patients with advanced hepatocellular carcinoma and severe liver dysfunction, according to the results of a randomized phase II trial.
Treatment with 3D conformal radiotherapy prior to hepatectomy significantly improved post-operative outcomes compared with surgery alone in patients with resectable hepatocellular carcinoma and portal vein tumor thrombus, according to the results of randomized study published in the <em>Journal of Clinical Oncology</em>.<br />
A dose-escalation strategy for giving regorafenib improved the frequency of adverse events while still demonstrating similar efficacy to a standard-dose strategy in patients with metastatic colorectal cancer.
Biologics License Application for enfortumab vedotin has been submitted to the FDA for a potential accelerated approval for use as a treatment for patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.
In the phase III PRIMA trial, niraparib demonstrated a benefit in progression-free survival compared with placebo when used as maintenance therapy following platinum-based chemotherapy for patients with ovarian cancer treated in the first line. The PFS benefit was found to be statistically significant, regardless of patients’ biomarker status, meeting the primary endpoint of the trial.
A Biologics License Application was submitted to the FDA seeking approval for a new subcutaneous formulation of daratumumab in select patients with multiple myeloma.
The FDA has granted an orphan drug designation to durvalumab (Imfinzi) for the treatment of patients with small cell lung cancer (SCLC).<br />
The FDA has accepted and is reviewing a Biologics License Application (BLA) for isatuximab as a potential treatment for patients with relapsed or refractory multiple myeloma. A target action date of April 30, 2020 has been set by the agency.<sup>1</sup><br />
The 4-drug regimen of daratumumab in combination with bortezomib, lenalidomide, and dexamethasone induced a high percentage of stringent complete responses compared with VRd alone in patients with newly diagnosed multiple myeloma who are eligible for high-dose chemotherapy and an autologous stem cell transplantation, according to topline results of the GRIFFIN trial. This met the primary endpoint of the phase II trial.
The FDA has granted a fast track designation for CLR 131 as a potential treatment for patients with relapsed or refractory diffuse large B-cell lymphoma. The designation was based on data from the DLBCL cohort of the ongoing phase II CLOVER-1 trial which is investigating CLR 131 in patients with relapsed/refractory B-cell lymphomas.
The FDA has accepted 6 supplemental Biologics License Applications (sBLAs) for review for a potential update to the dosing schedule for pembrolizumab across several indications.
Updated results from an interim analysis of the phase III BEACON CRC trial demonstrated a significant improvement in overall survival for the triplet regimen of encorafenib, binimetinib, and cetuximab compared with cetuximab and irinotecan-containing regimens in patients with previously treated <em>BRAF </em>V600E–mutant metastatic colorectal cancer.
Preventive strategies for severe diarrhea associated with adjuvant treatment with neratinib improved tolerability for the agent when patients received budesonide or colestipol-with-loperamide prophylaxis, according to findings from the CONTROL study.
At 3 years of follow-up, the combination of acalabrutinib and obinutuzumab continued to show benefit in patients with both newly diagnosed chronic lymphocytic leukemia and relapsed or refractory disease.
Selinexor has received an accelerated approval from the FDA for use in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥4 prior therapies and whose disease is refractory to ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-CD38 monoclonal antibody.
The development of an immune-related adverse event was associated with improved patient response in an FDA analysis of patients with advanced urothelial cancer treated with a PD-1/PD-L1 inhibitor.
The FDA approved a supplemental New Drug Application for avatrombopag as a treatment for adult patients with chronic immune thrombocytopenia who have had an insufficient response to a prior therapy.
A supplemental New Drug Application has been submitted to the FDA for the potential approval of neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have progressed on 2 or more prior HER2-targeted treatments.
The FDA has approved Zirabev, a biosimilar to bevacizumab for 5 indications. Zirabev has been approved for the treatment of patients with metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non–small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.
Frontline durvalumab led to a statistically significant and clinically meaningful improvement in overall survival (OS) in combination with etoposide and platinum-based chemotherapy in patients with extensive-stage small cell lung cancer, according to the results of a planned interim analysis of the phase III CASPIAN trial.
The RET inhibitor BLU-667 induced durable responses in patients with advanced, <em>RET-</em>altered medullary thyroid cancer and papillary thyroid cancer, according to updated results of the ARROW trial focused on the patients with thyroid cancer that were presented at the 2019 ASCO Annual Meeting.
During a recent <em>Targeted Oncology </em>live case-based peer perspectives presentation, Mary Jo J. Fidler, MD, reviewed treatment options in the first and second line based on a case study of a patient with NSCLC who experiences rapid progression on her first-line regimen.
Lisocabtagene maraleucel demonstrated a promising response rate and an acceptable toxicity profile in the TRANSCEND NHL 001 trial in a cohort of patients with relapsed or refractory mantle cell lymphoma.<br />
The FDA has lifted a partial clinical hold placed on the phase III CANOVA trial, which is investigating the combination of venetoclax and dexamethasone in comparison with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma and a transformation (11;14) abnormality.
Sorafenib in combination with hepatic arterial infusion chemotherapy demonstrated an improvement in overall survival compared with sorafenib alone for patients with hepatocellular carcinoma and portal vein invasion, according to the results of a randomized phase III trial.
A review of patients with advanced non–small cell lung cancer treated in a community practice setting demonstrated that not all patients recommended for receiving genomic testing are being appropriately tested for potential genetic drivers of disease.<br />
Preliminary results from a phase II trial demonstrated promising activity for brigatinib in patients with non–small cell lung cancer with an <em>ALK </em>rearrangement who have progressed on treatment with another next-generation ALK tyrosine kinase inhibitor.
The FDA has granted a fast track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.<br />
A phase III trial has begun for the investigational agent pemigatinib in comparison with gemcitabine and cisplatin chemotherapy for the treatment of newly diagnosed patients with metastatic or surgically unresectable cholangiocarcinoma who have activating <em>FGFR2 </em>rearrangements. The first patient has already been treated with the selective FGFR inhibitor in the open-label, randomized FIGHT-302 trial, according to a press release from Incyte, the company developing the agent.