Silas Inman

An overall disease control rate of 45% was achieved with sacituzumab govitecan (IMMU-132) therapy in patients with heavily pretreated metastatic triple-negative breast cancer (mTNBC), according to updated findings of a study presented at the 2017 San Antonio Breast Cancer Symposium (SABCS). 

For patients with advanced cancers, including melanoma, non–small cell lung cancer, and renal cell carcinoma, the combination of the CD122-biased cytokine NKTR-214 and the PD-1 inhibitor nivolumab (Opdivo) demonstrated target lesion reductions of 72%, according to findings from the phase Ib PIVOT-02 trial presented at the 2017 SITC Annual Meeting.

According to findings presented at the 2017 World Conference on Lung Cancer, the&nbsp;potent and selective inhibitor of ROS1 and TRKentrectinib induced an objective response rate of 68.8% by blinded independent central review, which included 2 complete responses (6.3%), for patients with <em>ROS1</em> fusion-positive advanced non&ndash;small cell lung cancer.

In topline results announced from the phase III IMpower150 trial, atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) and chemotherapy delayed progression or death when compared with bevacizumab and chemotherapy alone for patients with advanced nonsquamous non&ndash;small cell lung cancer.

Vemurafenib (Zelboraf) has been granted approval by the FDA&nbsp;as a treatment for patients with <em>BRAF</em> V600-mutated Erdheim-Chester disease (ECD). This is the first approved therapy for this rare blood disorder.

Brentuximab vedotin&nbsp;(Adcetris) has been submitted for FDA approval in combination with Adriamycin, vinblastine, dacarbazine for the frontline treatment of patients with&nbsp;advanced classical Hodgkin lymphoma.&nbsp;Seattle Genetics,&nbsp;the company developing brentuximab vedotin, recently announced the submission of a&nbsp;supplemental new drug application for the&nbsp;CD30-targeted antibody-drug conjugate.

Acalabrutinib (Calquence) received an accelerated approval from the FDA for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least 1 prior regimen.

Adjuvant treatment with a combination of dabrafenib (Tafinlar) and trametinib (Mekinist) continues to show a long-term survival benefit in patients with melanoma, even across subgroup populations, according to a presentation at the 2017 World Congress of Melanoma (WCM).

In a small phase I study, engineered tumor-infiltrating lymphocytes demonstrated signs of antitumor activity in patients with metastatic melanoma following treatment with a prior checkpoint inhibitor. Results of the pilot study of TILs that were engineered to express&nbsp;transforming growth factor-&beta; dominant negative receptor and nerve growth factor receptor were presented during the 2017 World Congress of Melanoma.

Triplet therapy with the combination of anti&ndash;PD-1/PD-L1 therapy, BRAF, and MEK inhibitors have already shown promise for patients with&nbsp;<em>BRAF</em>-positive advanced melanoma, and the potential for these combinations are increasing, according to Antoni Ribas, MD, PhD.&nbsp;

The CD19-directed CAR T-cell therapy&nbsp;axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the FDA for the treatment of adults with relapsed or refractory non-Hodgkin lymphoma (NHL), based on complete remission (CR) rate results from the phase II ZUMA-1 trial.

A supplemental new drug application for lenvatinib as a frontline systemic treatment for patients with advanced hepatocellular carcinoma has been accepted by the FDA, acccording to a statement from Eisai,&nbsp;the company developing the therapy.

Frontline treatment with the combination of&nbsp;dabrafenib and trametinib induced an&nbsp;objective response rate of 64% (95% CI, 46%-79%) and a disease control rate of 75% in patients with&nbsp;<em>BRAF</em>-mutant metastatic non&ndash;small cell lung cancer.

After a median follow-up of 2.8 years, the 3-year relapse-free survival rate in patients with <em>BRAF</em>-mutant stage III melanoma&nbsp;who were treated with adjuvant dabrafenib and trametinib was 58% compared with 39% for placebo,&nbsp;according to findings&nbsp;from the phase III COMBI-AD study.

When abemaciclib was added to a non-steroidal aromatase inhibitor in treatment-naive patients with HER2-negative, HR-positive advanced breast cancer, the combination reduced the risk of progression of disease or death by 46% compared with either anastrozole or letrozole alone, according to findings from the phase III MONARCH 3 trial.

For patients with <em>BRAF</em>-mutant advanced melanoma, the&nbsp;BRAF inhibitor encorafenib combined with the MEK inhibitor binimetinib demonstrated significant improvements in progression-free survival (PFS) compared with single-agent vemurafenib or encorafenib, according to updated findings from the phase III COLUMBUS trial presented at the 2017 ESMO Congress.

Treatment with the PD-L1 inhibitor durvalumab (Imfinzi) improved median PFS by 11.2 months compared with placebo for patients with locally advanced, unresectable stage III non&ndash;small cell lung cancer who had not progressed following chemoradiotherapy, according to phase III results from the PACIFIC trial presented at the 2017 ESMO Congress.

In results from the phase III FLAURA study of frontline osimertinib (Tagrisso) in patients with <em>EGFR</em>-mutant non&ndash;small cell lung cancer, osimertinib demonstrated a progression-free survival &nbsp;rate of 18.9 months (95% CI, 12.5-21.4), which was significantly improved over standard therapy.&nbsp;

According to findings from the phase III ALUR and ALEX studies announced ahead of the 2017 ESMO Congress,^&nbsp;Alectinib demonstrated promising efficacy for patients with <em>ALK</em>-translocated non&ndash;small cell lung cancer with central nervous system metastases in both the first- and second-line setting.

The PARP inhibitor Rucaparib (Rubraca) improved median progression-free survival by 11.2 months compared with placebo as a maintenance treatment for patients with <em>BRCA</em>-mutant platinum-sensitive ovarian cancer, according to findings from the phase III ARIEL3 trial presented at the 2017 ESMO Congress.&nbsp;

The FDA has granted its approval to olaparib tablets (Lynparza) as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy, regardless of <em>BRCA</em> status.

Inotuzumab ozogamicin (Besponsa) has received FDA approval for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), based on findings from the phase III INO-VATE trial.

The combination of carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone reduced the risk of death by 21% compared with lenalidomide and dexamethasone alone for patients with relapsed multiple myeloma following prior treatment with 1 to 3 regimens.

Roy S. Herbst, MD, PhD, discusses how the therapeutic paradigm will continue to evolve in the next few years for&nbsp;non&ndash;small cell lung cancer, with an increased emphasis on rational combinations and biomarkers.

David R. Gandara, MD, discusses toxicity management with the combination of&nbsp;dabrafenib and trametinib in&nbsp;non&ndash;small cell lung cancer.

CPX-351 (Vyxeos), a fixed-combination of daunorubicin and cytarabine, has been approved by the FDA for adult patients with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC), based on an improvement in overall survival (OS) in a phase III study.

Enasidenib (Idhifa) has been approved by the FDA as a treatment for patients with relapsed or refractory <em>IDH2</em>-mutated acute myeloid leukemia (AML), based on findings from a phase I/II study. A companion diagnostic, the RealTime IDH2 Assay, was also approved for the detection of the <em>IDH2</em> mutation.

Checkpoint inhibitors against PD-1 and PD-L1 have demonstrated promising efficacy as monotherapies and in combination with chemotherapy for patients with triple-negative breast cancer, with phase III data on the horizon

Blinatumomab (Blincyto) has been granted a full approval by the FDA as a treatment for adults and children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia, regardless of Philadelphia chromosome status.

Panitumumab has been approved by the FDA in combination with FOLFOX as a frontline treatment for patients with <em>RAS</em> wild-type metastatic colorectal cancer.