Silas Inman

The European Commission has approved osimertinib (Tagrisso) as a frontline treatment for patients with EGFR-mutant locally-advanced or metastatic non–small cell lung cancer.

Several studies presented at the 2018 ASCO Annual Meeting helped further refine and inform treatment strategies for the budding class of CAR T-cell therapies, with a focus on predicting adverse events and optimizing efficacy.

The combination of nivolumab and low-dose ipilimumab reduced the risk of progression or death by 52% compared with standard platinum doublet chemotherapy for patients with metastatic PD-L1–negative, tumor mutation burden-high non–small cell lung cancer.

The combination of atezolizumab, bevacizumab, carboplatin, and paclitaxel educed the risk of death by 22% compared with bevacizumab and chemotherapy in patients with advanced wild-type non-squamous non–small cell lung cancer.

Lisocabtagene maraleucel (JCAR017; liso-cel) demonstrated a durable complete remission rate of 46% at 6 months for patients with high-risk diffuse large B-cell lymphoma.

Similar efficacy with the combination of rituximab and lenalidomide coupled with a better safety profile compared with rituximab plus chemotherapy may make the chemo-free regimen a new frontline option for patients with previously untreated follicular lymphoma.

The frontline combination of ibrutinib and venetoclax demonstrated a 100% objective response rate for patients with chronic lymphocytic leukemia, with 77% of patients testing negative for minimal residual disease in the peripheral blood after 6 cycles.

The highly-selective RET inhibitor LOXO-292 demonstrated robust clinical activity across RET-altered solid tumors, including in patients with brain metastases and the RET V804M gatekeeper mutation.

bb2121 had a median progression-free survival of 11.8 months and a median duration of response of 10.8 months for patients with relapsed/refractory heavily pretreated multiple myeloma.

The addition of venetoclax to carfilzomib and dexamethasone demonstrated a 100% objective response rate with a very good partial response or better rate of 86% for patients with relapsed/refractory t(11;14) multiple myeloma.

The FDA has accepted a supplemental new drug application for cabozantinib as a treatment for patients with previously-treated advanced hepatocellular carcinoma.

Two separate early-phase clinical trials exploring daratumumab in combination with either a PD-1 inhibitor for multiple myeloma or a PD-L1 inhibitor for non–small cell lung cancer were terminated following a planned interim analysis.

The FDA has extended the review period for lenvatinib as a first-line treatment for patients with unresectable hepatocellular carcinoma. The new action date for the supplemental new drug application is August 24, 2018.

The FDA has approved a new formulation of abiraterone acetate in combination with methylprednisolone as a treatment for men with metastatic castration-resistant prostate cancer.

IMCgp100, a novel immune-based treatment, demonstrated a 1-year survival rate of 73% for patients with heavily pretreated, which is nearly double the historical expectations for patients with the disease.

The FDA has issued a drug safety notification warning against the use of frontline single-agent immune checkpoint inhibition for patients with PD-L1–low expressing platinum-eligible urothelial carcinoma.

A shorter 6-month course of adjuvant trastuzumab (Herceptin) was found to be noninferior for disease-free survival compared with the standard 12-month schedule for patients with HER2-positive early breast cancer.

The FDA has approved daratumumab in combination with bortezomib, melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Second-line regorafenib (Stivarga) continued to show antitumor activity regardless of prior dose or time to progression on frontline sorafenib (Nexavar) for patients with unresectable advanced hepatocellular carcinoma.

The FDA has approved the SYK inhibitor fostamatinib as a second-line treatment for patients with chronic immune thrombocytopenia following insufficient response to a previous therapy.

Treatment with nivolumab reduced the risk of death by 32% compared with investigator’s choice of therapy for patients with metastatic or recurrent squamous cell carcinoma of the head and neck.

Treatment with crizotinib elicited an objective response rate of 50% for patients with ALK-positive advanced, inoperable inflammatory myofibroblastic tumor.

Abemaciclib (Verzenio) has quickly amassed several clinical indications for patients with metastatic breast cancer, and is the only CDK4/6 inhibitor approved as a single agent.

The PARP inhibitors have finally become available for patients with BRCA-mutant metastatic breast cancer, ushering in a potential new era for targeted therapies with studies currently ongoing in the adjuvant setting and exploring combinations.

Improvements in progression-free survival with olaparib (Lynparza) remained consistent regardless of baseline tumor burden for patients with HER2-negative breast cancer with a germline BRCA1/2 mutation.

The past decade of drug discovery has brought a dramatic expansion in the number of new therapies to treat patients with advanced or metastatic melanoma in 2 modalities: checkpoint blockade immunotherapies and molecularly targeted drugs.

The FDA has granted a priority review designation to ivosidenib (AG-120) for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia.

Bristol-Myers Squibb and Nektar Therapeutics have announced plans to jointly develop and market combinations of the CD122-biased cytokine NKTR-214 with nivolumab (Opdivo) or nivolumab plus ipilimumab (Yervoy) across for 20 indications in 9 tumor types.

The FDA has approved abiraterone acetate in combination with prednisone and androgen deprivation therapy for high-risk patients with metastatic hormone-naïve prostate cancer or newly-diagnosed metastatic hormone-sensitive prostate cancer.

The combination of atezolizumab and bevacizumab reduced the risk of progression or death by 26% compared with sunitinib for patients with untreated PD-L1–positive metastatic renal cell carcinoma.