Lisa Astor

Belantamab mafodotin, an investigational antibody–drug conjugate, demonstrated a clinically meaningful overall response rate among patients with relapsed multiple myeloma in early results from the DREAMM-2 trial, according to a press release from GlaxoSmithKline. This met the primary endpoint of the pivotal phase II trial.

Selinexor plus dexamethasone induced objective responses and a significant overall survival among heavily pretreated patients with multiple myeloma, according to results from the phase IIb STORM trial published in&nbsp;<em>The New England Journal of Medicine.</em>

The FDA has granted a New Drug Application for zanubrutinib a priority review for the treatment of patients with mantle cell lymphoma who have previously received at least 1 prior treatment.

A recent study of patients with differentiated thyroid cancer (DTC) who were surveyed about their perceived choice in receiving radioactive iodine (RAI) treatment suggests the need for increased shared decision making between physicians and their patients regarding treatment choices.

The FDA has granted a priority review to a supplemental New Drug Application for a new indication for enzalutamide as a treatment for men with metastatic hormone-sensitive prostate cancer.

The combination of durvalumab and tremelimumab did not meet its primary overall survival endpoint compared with platinum-based chemotherapy in patients with previously untreated stage IV non&ndash;small cell lung cancer and a high tumor mutational burden, according to final OS results from the phase III NEPTUNE trial.

A combination of vorinostat, cladribine, and rituximab demonstrated high, durable rates of complete response in patients with previously untreated mantle cell lymphoma, according to the results of a phase I/II trial of the triplet regimen in patients with non-Hodgkin lymphoma.<br /> &nbsp;

The FDA has approved the treatment of fedratinib for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis, including post-polycythemia vera or post-essential thrombocythemia myelofibrosis.

The FDA has approved entrectinib for the treatment of adult patients with <em>ROS1</em>-positive metastatic non&ndash;small cell lung cancer. An accelerated approval was also granted to entrectinib for the treatment of adult and adolescent patients with solid tumors harboring an <em>NTRK </em>gene fusion and who have no alternative, effective therapies available.

In the largest genomic study of Merkel cell carcinoma tumors to date, investigators identified 2 distinct molecular subgroups, an ultraviolet light&ndash;driven subtype and a viral-driven subtype, which matched with tumor mutational burden classifications.&nbsp;

The FDA has granted a breakthrough therapy designation to acalabrutinib monotherapy for the treatment of adult patients with chronic lymphocytic leukemia.&nbsp;The breakthrough designation was given based on the results of interim analyses from 2 phase III trials: ELEVATE-TN and ASCEND.&nbsp;

Olaparib in combination with bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival as a frontline maintenance regimen compared with bevacizumab alone in women with advanced ovarian cancer, according to early results from the phase III PAOLA-1 trial.

Ripretinib demonstrated a significantly improved progression-free survival compared with placebo in patients with gastrointestinal stromal tumors being treated in the fourth-line setting or beyond, according to topline results from the phase III INVICTUS trial. An NDA for ripretinib is planned for the first quarter of 2020.&nbsp;

Vicinium has demonstrated positive 12-month complete response rate findings in the VISTA trial of patients with high-risk patients with non&ndash;muscle-invasive bladder cancer who were unresponsive to bacillus Calmette-Gu&eacute;rin treatment, according to updated preliminary findings from the phase III clinical trial.

Osimertinib has demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with standard first-generation EGFR tyrosine kinase inhibitors in patients with newly diagnosed <em>EGFR</em>-mutated non&ndash;small cell lung cancer, according to updated findings from the phase III FLAURA trial.

Overall survival was not improved with the use of lefitolimod as a maintenance therapy compared with local standard-of-care therapy in patients with metastatic colorectal cancer, according to early findings from the pivotal phase III IMPALA trial. The median OS was 22.0 months with lefitolimod compared with 21.9 months with standard of care, which failed to meet the primary endpoint of the trial.

The FDA has granted a priority review to a New Drug Application for avapritinib as a treatment for adult patients with <em>PDGFRA</em> exon 18&ndash;mutant gastrointestinal stromal tumors, regardless of prior therapy, and in the fourth-line setting for GIST.

Olaparib demonstrated a statistically significant improvement in radiographic progression-free survival compared with enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer who have a homologous recombination repair mutation and have progressed on prior treatment with new hormonal anticancer treatments, according to early findings from the PROfound trial.

A phase III clinical trial has begun to investigate the use of cemiplimab as an adjuvant treatment after surgery and radiation therapy in patients with high-risk cutaneous squamous cell carcinoma.<br /> &nbsp;

Sequential afatinib followed by osimertinib has demonstrated a long-term overall survival of close to 4 years in patients with non&ndash;small cell lung cancer who have <em>EGFR </em>deletion 19&ndash;positive tumors and acquired T790M mutations, according to interim results released from the real-world GioTag study.

Ribociclib in combination with fulvestrant demonstrated a statistically significant improvement in overall survival in postmenopausal women with hormone receptor&ndash;positive, HER2-negative advanced or metastatic breast cancer, according to interim results from the phase III MONALEESA-3 trial.

Nivolumab demonstrated long-term survival benefit in heavily pretreated patients with advanced melanoma, renal cell carcinoma, and non&ndash;small cell lung cancer, according to an analysis of 5-year results from the CA209-003 trial. The analysis also identified favorable and adverse factors associated with survival that could inform future use of nivolumab.&nbsp;

The FDA has approved pembrolizumab monotherapy as a treatment for patients with recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1, as determined by an FDA-approved test, and who have disease progression after &ge;1 prior systemic regimen.&nbsp;

The combination of abemaciclib and fulvestrant has demonstrated a statistically significant improvement in overall survival compared with fulvestrant and placebo in women with HR&ndash;positive, HER2-negative advanced or metastatic breast cancer who have previously received endocrine therapy, according to updated interim results from the phase III MONARCH 2 trial.

The combination of pembrolizumab with chemotherapy demonstrated a benefit in terms of pathological complete response when used as neoadjuvant therapy compared with chemotherapy alone in patients with triple-negative breast cancer, according to interim results of the pivotal phase III KEYNOTE-522 trial.

Nivolumab in combination with a low dose of ipilimumab demonstrated an improvement in overall survival compared with chemotherapy in patients with newly diagnosed non&ndash;small cell lung cancer whose tumors have PD-L1 expression&nbsp;&ge;1%.

The FDA has granted an orphan drug designation to MB-102, a CD123-directed CAR T-cell therapy, for the treatment of patients with acute myeloid leukemia.

The FDA has granted a breakthrough therapy designation for the combination of pembrolizumab and lenvatinib for the treatment of patients with newly diagnosed, advanced, unresectable hepatocellular carcinoma that is not amenable to locoregional treatment.

The results of the phase III PACIFIC trial made a significant impact on the treat&shy;ment landscape for locally advanced non&minus;small cell lung cancer when both the progression-free survival and overall survival results were announced separately.

The FDA has approved an update to the durvalumab label for patients with unresectable, stage III non&ndash;small cell lung cancer whose disease has not progressed following concurrent platinum-based chemoradiotherapy in order to include overall survival data from the phase III PACIFIC trial.<br /> &nbsp;