Lisa Astor

The combination of daratumumab plus bortezomib, thalidomide, and dexamethasone (VTD) has been approved by the FDA for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.

The investigational agent UGN-101 induced a complete response in 59% of patients with low-grade upper tract urothelial cancer in the phase III OLYMPUS trial, according to findings from a final analysis of the pivotal trial. 

Now in it 24th year, the annual International Congress on Hematologic Malignancies: Focus on Leukemias, Lymphomas, and Myeloma, hosted by Physicians’ Education Resource, LLC, continues to bring significant advances in hematology to the forefront.

The FDA has expanded the indication for the Cologuard noninvasive screening test for colorectal cancer to include eligible patients with an average risk of developing colorectal cancer who are between the ages of 45 and 49.

The FDA has granted a fast track designation to abexinostat for the treatment of patients with relapsed or refractory follicular lymphoma in the fourth-line setting.<br /> &nbsp;

In an interview with <em>Targeted Oncology</em>, Mar&iacute;a Varela, MD, PhD, discussed the rationale of the findings from the real-life analysis and their importance for patients with HCC being treated outside of a clinical trial.

Treatment with regorafenib resulted in higher rates of alpha-fetoprotein level response compared with placebo in patients with unresectable hepatocellular carcinoma who had progressed on prior sorafenib, according to an analysis from the phase III RESORCE trial.

The FDA has approved a supplemental New Drug Application for apalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer.

The FDA has granted an accelerated approval to the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced endometrial cancer who have disease progression following prior systemic therapy. The indication applies to patients who are not candidates for curative surgery or radiation and who have disease that is not microsatellite instability&ndash;high or mismatch repair deficient.

The combination of carfilzomib, dexamethasone, and daratumumab led to a 37% reduction in the risk of progression or death compared with carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma in the phase III CANDOR trial. According to a press release from Amgen, this met the primary endpoint of progression-free survival for the trial.

The FDA has issued a warning for a rare, but severe, lung inflammation that could be caused by the use of CDK4/6 inhibition in patients with advanced breast cancers.&nbsp;The warning applies to treatment with palbociclib, ribociclib, and abemaciclib specifically, but warnings of the risk of lung inflammation have been approved to be added to the prescribing information for the entire class of CDK4/6 inhibitors.

The FDA has granted a priority review to a Biologics License Application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting and a PD-1/PD-L1 checkpoint inhibitor.

In the phase III QUAZAR AML-001 trial, an investigational oral azacitidine therapy, CC-486, induced a statistically significant improvement in overall survival compared with placebo when used as a maintenance therapy in the treatment of patients with newly diagnosed acute myeloid leukemia who achieved a complete response or CR with incomplete blood count recovery following treatment with induction chemotherapy.

Naveen Pemmaraju, MD, discussed potential combination regimens with ruxolitinib (Jakafi) being explored to improve outcomes for patients with myelofibrosis at the 2019 SOHO Annual Meeting.&nbsp;

Avelumab demonstrated promising efficacy in treating patients with mismatch repair&ndash;deficient endometrial cancer, according to the results of a phase II study published in the&nbsp;Journal of Clinical Oncology.&nbsp;

Atezolizumab monotherapy demonstrated a statistically significant overall survival benefit in comparison with chemotherapy doublets in patients with untreated advanced non&ndash;small cell lung cancer with high PD-L1 expression and without <em>ALK </em>or <em>EGFR </em>mutations. This met the primary endpoint for the phase III IMpower110 trial, according to initial results release by Genentech, the developer of the PD-L1 inhibitor.

The FDA has accepted a supplemental New Drug Application for the use of neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer following failure of &ge;2 prior lines of HER2-directed therapy.

Cabazitaxel in combination with carboplatin demonstrated an improvement in progression-free survival in comparison with cabazitaxel alone in men with metastatic castration-resistant prostate cancer. Adverse events were more common with the combination regimen, but the doublet was generally well tolerated.

The FDA has granted a breakthrough therapy designation to tepotinib, an investigational MET inhibitor, for the treatment of patients with metastatic non&ndash;small cell lung cancer harboring a&nbsp;MET&nbsp;exon 14 skipping alteration who have progressed following platinum-based therapy.

Treatment with selpercatinib induced responses in 68% of patients with&nbsp;<em>RET&nbsp;</em>fusion&ndash;positive non&ndash;small cell lung cancer, according to findings from the phase I/II LIBRETTO-001 trial.

The FDA has granted a fast track designation to AMG 510 for the treatment of patients with previously treated metastatic non&ndash;small cell lung cancer harboring a&nbsp;<em>KRAS&nbsp;</em>G12C mutation.

The FDA has granted capmatinib a breakthrough therapy designation as a first-line treatment for patients with <em>MET </em>exon 14 skipping mutation&ndash;positive non&ndash;small cell lung cancer.

The addition of nivolumab to the standard of care temozolomide and radiation therapy was not additive in terms of progression-free survival compared with standard of care alone in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase-methylated, according to results released from the phase III CheckMate 548 trial.

Men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer who had baseline prostate-specific antigen levels &le;5.27 ng/mL demonstrated a median overall survival approaching 4 years with sipuleucel-T treatment, according to findings from the large real-world PROCEED trial.

An ongoing phase IIa clinical trial has demonstrated the safety and efficacy of milciclib maleate at 6 months in patients with unresectable or metastatic hepatocellular carcinoma who were resistant or intolerant to sorafenib.

The FDA has granted a fast track designation to magrolimab for the treatment of patients with acute myeloid leukemia and myelodysplastic syndrome.

The FDA has granted neratinib with an orphan drug designation for the treatment of patients with breast cancer&ndash;related brain metastases.

The FDA has granted nirogacestat, an investigational gamma-secretase inhibitor, with a breakthrough therapy designation for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

The addition of ixazomib to a combination of mitoxantrone, etoposide, and cytarabine demonstrated a promising rate of responses among patients with relapsed or refractory acute myeloid leukemia, according to the results of a phase I/II trial.

PD-L1 positivity in patients with medullary thyroid cancer is associated with more aggressive clinicopathological features and predictive of structural and biochemical recurrences, according to the results of a retrospective Chinese study.