Gina Columbus

The combination of regorafenib and nivolumab will be compared with regorafenib alone in a phase III trial of patients with microsatellite stable colorectal cancer, following encouraging phase Ib findings of the REGONIVO study.

Health Canada has approved neratinib (Nerlynx) for the extended adjuvant treatment of patients with early-stage, hormone receptor–positive, HER2-overexpressed/amplified breast cancer within 1 year after completing trastuzumab (Herceptin)-based adjuvant therapy.

A biologics license application has been submitted to the FDA for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/PD-L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.

Niraparib as a maintenance treatment demonstrated a statistically significant improvement in progression-free survival compared with placebo in patients with ovarian cancer following first-line platinum-based chemotherapy, regardless of biomarker status, meeting the primary endpoint of the phase III PRIMA (ENGOT-OV26/GOG-3012) trial.

A supplemental biologics license application has been submitted to the FDA for a new subcutaneous formulation of daratumumab (Darzalex) for the treatment of patients with multiple myeloma.

The FDA has granted an Orphan Drug Designation to durvalumab for the treatment of patients with small cell lung cancer, according to AstraZeneca, the developer of the PD-L1 inhibitor.

Ariela Noy, MD, discusses a phase II trial of devimistat in Burkitt lymphoma and other lymphomas, and describes the unique mechanism of action of the agent.

The oral modified dysfunctional tyrosine SM-88 demonstrated a median overall survival of 6.4 months in patients with advanced pancreatic cancer.

The FDA has accepted 6 supplemental biologics license applications for review to update the dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg over 30-minute infusions.

The quadruplet regimen of daratumumab, lenalidomide, bortezomib, and dexamethasone elicited a higher stringent complete response rate compared with lenalidomide, bortezomib, and dexamethasone alone in patients with transplant-eligible, newly diagnosed multiple myeloma, meeting the primary endpoint of the phase II GRIFFIN study.

Encorafenib, binimetinib, and cetuximab demonstrated a significant improvement in overall survival compared with cetuximab and an irinotecan-containing regimen in patients with BRAF-mutant colorectal cancer.

Alison R. Sehgal, MD, discusses the latest developments with CAR T-cell therapy in lymphomas.

The FDA has granted an accelerated approval to selinexor 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 a CD38-targeted monoclonal antibody.

The CanStem111P trial, which was evaluating the combination of napabucasin, weekly nab-paclitaxel (Abraxane), and gemcitabine compared with nab-paclitaxel/gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma, will be discontinued due to futility.

The FDA has approved a supplemental new drug application to expand the use of avatrombopag to include the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to prior therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended expanding the indications of ibrutinib (Imbruvica) to include use in combination with obinutuzumab (Gazyva) for adult patients with previously untreated chronic lymphocytic leukemia, and also in combination with rituximab (Rituxan) for the treatment of adult patients with Waldenström’s macroglobulinemia.

The FDA has approved PF-06439535, a bevacizumab biosimilar, for the treatment of patients with metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent, or metastatic cervical cancer.

The FDA has approved the combination of daratumumab with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

Durvalumab combined with standard etoposide and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with standard chemotherapy alone as a first-line treatment in patients with extensive-stage small cell lung cancer, meeting the primary endpoint of the phase III CASPIAN trial (NCT03043872).

MAPK/ERK gene alterations, primarily receptor tyrosine kinases, BRAF, and CDK4/6 amplifications, were found to be present in more than half of patients with heavily pretreated metastatic prostate cancer.

The FDA has lifted a partial clinical hold that was placed on the phase III CANOVA (M13-494; NCT03539744) trial, which is examining venetoclax in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma that harbors t(11;14), according to AbbVie, the company that co-develops the BCL-2 inhibitor with Roche.

The FDA has granted a priority review designation to a supplemental biologics license application for niraparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 or more prior chemotherapy regimens, and who have either a BRCA mutation or have homologous recombination deficiency and progressed >6 months after their last platinum-based chemotherapy.

Nivolumab (Opdivo) did not achieve statistical significance for improved overall survival compared with sorafenib (Nexavar) as a frontline therapy for patients with unresectable hepatocellular carcinoma as per a prespecified analysis, missing the primary endpoint of the phase III CheckMate-459 trial.

The European Commission has approved single-agent talazoparib for the treatment of adult patients with germline BRCA1/2-mutant, HER2-negative locally advanced or metastatic breast cancer.

The combination of atezolizumab (Tecentriq) and cobimetinib (Cotellic) did not improve progression-free survival compared with pembrolizumab (Keytruda) in patients with previously untreated BRAF V600 wild-type melanoma, missing the primary endpoint of the phase III IMspire170 trial.

Japan’s Pharmaceuticals and Medical Devices Agency approved olaparib as a maintenance treatment for patients with BRCA-mutant ovarian cancer after undergoing first-line chemotherapy.

The Ministry of Health, Labor and Welfare of Japan has approved quizartinib for the treatment of adult patients with relapsed/refractory FTL3-ITD–positive acute myeloid leukemia, as detected by an MHLW-approved assay.

The European Commission has approved olaparib as a single agent for the maintenance treatment of adult patients with advanced BRCA1/2-mutated germline and/or somatic high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following first-line platinum-based chemotherapy.

The FDA has granted an accelerated approval to single-agent pembrolizumab for the treatment of patients with metastatic small cell lung cancer who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy.

Pfizer Inc. has entered into a definitive merger agreement with Array BioPharma, in which Pfizer will acquire Array BioPharma for $48 per share in cash, leading to a total enterprise value of an estimated $11.4 billion.