Jason Harris

A new drug application for lorlatinib for use in patients with&nbsp;<em>ALK</em>-positive metastatic non&ndash;small cell lung cancer who have progressed on 1 or more ALK tyrosine kinases inhibitors has been granted a priority review by the FDA.

During the 2018 Society of Gynecologic Oncology Annual Winter Meeting, Camille Gunderson, MD,&nbsp;detailed some of the active trials currently exploring PARP inhibitors in combination with either anti-VEGF therapy or immunotherapy in ovarian cancer.

Findings from a phase Ia, multicenter, open-label, study published in the&nbsp;<em>Journal of Clinical Oncology</em>&nbsp;showed a disease control rate of 58.2% with alpelisib (BYL719) in patients with advanced solid tumors.

Based on data from part 1a of the phase III CheckMate-227 trial, nivolumab (Opdivo) and&nbsp;ipilimumab (Yervoy) in combination show improved progression-free survival (PFS) versus with chemotherapy in treatment-na&iuml;ve patients with high tumor mutation burden (TMB) non&ndash;small cell lung cancer (NSCLC).

Overall survival was extended for patients with relapsed or refractory multiple myeloma by nearly 8 months with the&nbsp;combination of carfilzomib, lenalidomide, and dexamethasone compared with&nbsp;lenalidomide and dexamethasone alone in results from the phase III ASPIRE trial.

Women with newly diagnosed stage III&nbsp;epithelial ovarian cancer experienced an improvement in&nbsp;relapse-free survival and overall survival with the addition of&nbsp;hyperthermic intraperitoneal chemotherapy to interval cytoreductive surgery, according to results&nbsp;from a multicenter, open-label, phase III trial.

According to results of an open-label, single-center, 2-stage, proof-of-concept phase II study, prexasertib (LY2606368), a cell cycle checkpoint kinase 1 and 2 inhibitor, demonstrated clinical activity and was tolerable in&nbsp;women with measurable, recurrent high-grade serous or high-grade endometrioid ovarian carcinoma.

In findings from the phase II&nbsp;MDV3100-11 study published in the<em> Journal of Clinical Oncology</em>, enzalutamide demonstrated early signs of efficacy in&nbsp;patients with androgen receptor-positive triple-negative breast cancer.

Progression-free survival was improved by nearly 15% with CHOP-RIT compared with R-CHOP alone in previously untreated patients with follicular lymphoma,&nbsp;according to findings from the phase III SWOG-S0016 trial published in the <em>Journal of Clinical Oncology</em>.

Treatment with cabozantinib induced similar quality of life results as treatment with everolimus in patients with advanced renal cell carcinoma, according to results of the&nbsp;randomized, open-label, international phase III METEOR trial.

Four US studies of&nbsp;BPX-501 have been halted by the FDA after&nbsp;3 patients developed encephalopathy possibly related to treatment with the&nbsp;novel cellular immunotherapy for cancers and orphan inherited blood disorders.

Circulating tumor cell conversion and CTC value &ge; 1 at baseline were superior predictors of overall survival than PSA in men with metastatic castration-resistant prostate cancer, according to an analysis of results from 5 clinical trials.<br /> &nbsp;

According to results of a subgroup analysis of the phase III METEOR trial, cabozantinib (Cabometyx) demonstrated a 4.7 month improvement in progression-free survival compared with everolimus&nbsp;(Afinitor)&nbsp;in pretreated patients with advanced renal cell carcinoma with bone metastases at baseline.

Pfizer has announced that PF-05280586, a biosimilar for rituximab, has delivered positive top-line results, meeting its primary endpoint for overall response rate in the&nbsp;in the phase III REFLECTIONS B3281006 trial for patients with follicular lymphoma.

Progression-free survival and overall survival were improved for patients with glioblastoma by adding tumor-treating fields to&nbsp;temozolomide (Temodar),&nbsp;according to a final analysis of results from the EF-14 trial.

According to results from the phase I JAVELIN Solid Tumor study recently published in the Lancet Oncology, the PD-L1 inhibitor avelumab (Bavencio) induced an overall response rate of 17% in patients with platinum-refractory metastatic urothelial carcinoma.

According to long-term follow-up results from the National Surgical Adjuvant Breast and Bowel Project B-31 trial published in the <em>Journal of Clinical Oncology</em>,<em>&nbsp;</em>trastuzumab (Herceptin) did not reduce cardiac function in women with node-positive,&nbsp;HER2+, early-stage breast cancer.

In results from the&nbsp;phase III CROSS trial reported in the <em>Journal of Clinical Oncology,&nbsp;</em>neoadjuvant chemoradiotherapy failed to lower postoperative health-related quality of life compared with surgery alone for patients with&nbsp;esophageal or junctional cancer.<br /> &nbsp;

According to findings from the phase III TERRA trial published in the <em>Journal of Clinical Oncology, </em>previously treated Asian patients with metastatic colorectal cancer saw a significant survival benefit with TAS-102&nbsp;(trifluridine and tipiracil; Lonsurf) compared with placebo.

According to a small,&nbsp;single-site prospective observation, women with ER-positive advanced high-grade serous ovarian cancer who received maintenance therapy with letrozole were more likely to be recurrence-free at 24 months, suggesting that letrozole may have a role to play in this setting,&nbsp;especially for patients with chemotherapy resistance or residual disease.<br /> &nbsp;

Eltrombopag (Promacta) has been granted a breakthrough therapy designation by the FDA for use&nbsp;in combination with standard immunosuppressive therapy&nbsp;for the first-line treatment of patients with severe aplastic anemia.

The proteasome inhibitor ixazomib has received a recommendation from the United Kingdom&#39;s National Institute for Health and Care Excellence for patients with relapsed/refractory multiple myeloma.

Pembrolizumab (Keytruda) has received a priority review from the FDA for a supplemental biologics license application (sBLA) for the treatment of&nbsp;adult and pediatric patients with relapsed/refractory primary mediastinal large B-cell lymphoma (PMBCL), according to a press release from Merck,&nbsp;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.

Treatment with a&nbsp;gonadotropin-releasing hormone analog could potentially preserve fertility and protect ovarian function in premenopausal woman being treated with chemotherapy for early-stage breast cancer, according to the results of a meta-analysis presented at the 2017 San Antonio Breast Cancer Symposium.

The FoundationOne CDx (F1CDx) cancer biomarker assay has been granted FDA approval&nbsp;concurrently with a decision from the Centers for Medicare &amp; Medicaid Services to provide insurance coverage for the next-generation sequencing NGS-based in vitro diagnostic test.

Niraparib&nbsp;(Zejula) has been approved by the European Commission as a maintenance therapy for women with platinum-sensitive relapsed high-grade serous&nbsp;epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy, Tesaro, the manufacturer of the treatment, has announced.

In patients with&nbsp;hepatocellular carcinoma (HCC), pill burden and treatment costs were reduced, with a trend toward improved treatment completion, by lowering the dose of&nbsp;sorafenib (Nexavar), according to results from a&nbsp;retrospective, multi-institutional study.

According to results from the phase II&nbsp;NCI9855 study, presented at&nbsp;the 2017 World Congress of Melanoma, glembatumumab vedotin (CDX-011) induced a 61%&nbsp;disease control rate in patients with&nbsp;metastatic uveal melanoma, despite a low a low objective response rate of 6%.

According to results of a phase I/II study, men with metastatic castration-resistant prostate cancer who received a second course of radium-223&nbsp;(Xofigo) experienced minimal hematologic toxicity and low radiographic bone progression rates.

Ribociclib (Kisqali) met its primary endpoint for progression-free survival (PFS) in premenopausal women with&nbsp;hormone-receptor (HR)&ndash;positive, HER2-negative (HR+/HER2-) advanced or metastatic breast cancer, according to topline results from the MONALEESA-7 trial, Novartis recently announced in a press release.