Danielle Ternyila

In cohort 1 of the phase III ASPEN trial, zanubrutinib demonstrated a higher very good partial response rate and a more tolerable safety profile compared with ibrutinib in patients with Waldenström macroglobulinemia. However, the study missed its primary end point of statistically significant superiority in complete response and VGPR rates, according to a press release from BeiGene, Ltd, developer of the BTK inhibitor.

Initial data from the phase II CLOVER-1 trial demonstrated an acceptable safety profile for CLR 131 in patients with relapsed/refractory B-cell malignancies, including multiple myeloma, Cellectar Biosciences, Inc., announced in a press release.

In an interview with Targeted Oncology, Pinkal Desai, MD, discussed the latest advancements in the treatment landscape for patients with AML, particularly for the older population. She also highlighted emerging treatment options that undergoing investigation now in clinical trials.

SP-2577, a potent reversible LSD1 inhibitor, has been granted Fast Track Designation by the FDA for the treatment of relapsed/refractory patients with Ewing sarcoma, Salarius Pharmaceuticals, Inc. developers of the drug, announced in a press release.

The Association of Community Cancer Centers has partnered with the AIM at Melanoma Foundation to develop resources through its Multidisciplinary Cutaneous Squamous Cell Carcinoma Care education project to help provide physicians with more information to guide them in the diagnosis and treatment of patients with this type of nonmelanoma skin cancer, according to a press release from ACCC.

MI Genomic Profiling Similarity Score, the latest addition to the comprehensive genomic profiling armamentarium at Caris Life Sciences, has been launched, according to a press release from the company

A New Drug Application for ripretinib was submitted to the FDA for the treatment of patients with advanced gastrointestinal stromal tumor who have received a prior treatment of imatinib, sunitinib, and regorafenib, according to a press release from Deciphera Pharmaceuticals, Inc.

Pembrolizumab showed improvements in overall survival, progression-free survival, and objective response rate compared with pemetrexed or paclitaxel chemotherapy in patients with metastatic nonsquamous non–small cell lung cancer whose tumors are PD-L1–positive, regardless of their KRAS mutational status.

In an interview with Targeted Oncology, Brennan J. Decker, MD, PhD, discussed a real-life scenario of a patient with lung cancer who harbored both an EGFR and BRAF mutation. He highlighted the key takeaways of this case, which he presented at the 2019 Association for Molecular Pathology Annual Meeting and Expo.

The United States Senate has voted to confirm Stephen M. Hahn, MD, FASTRO, as commissioner of Food and Drugs, Department of Health and Human Services during a U.S. Senate floor proceeding held on Thursday, December 12, 2019, according to a press release from the HHS. The vote was 72 to 18.

Following the 2019 ASH Annual Meeting, Targeted Oncology spoke with experts from various specialties in hematology. The experts highlighted some of the top abstracts from the meeting that will impact the way multiple myeloma, leukemias, MPNs, and lymphomas are treated.

In an interview with Targeted Oncology, Jorge J. Castillo, MD, discussed the findings from the prospective phase II trial evaluating venetoclax in patients with Waldenström macroglobulinemia. He also addressed the unmet needs in this patient population and the next steps for research in the field.

The phase III BELLINI trial demonstrated translocation 11;14 and high BCL2 gene expression are predictive of response to treatment with the addition of venetoclax to bortezomib plus dexamethasone in patients with relapsed/refractory multiple myeloma, according to the findings presented at the 2019 ASH Annual Meeting.

In an interview with Targeted Oncology, Thomas Yau, MD, discussed the findings from the phase III CheckMate trial evaluating nivolumab in patients with advanced hepatocellular carcinoma compared with standard-of-care sorafenib. He highlighted the next steps for the trial following these data, which were presented at the 2019 European Society of Medical Oncology Congress.

In an interview with Targeted Oncology, Katja Weisel, MD, discussed the safety findings of the 4-drug chemotherapy regimen in the GMMG-CONCEPT trial, which were presented at the 17^th International Myeloma Workshop.

In an interview with Targeted Oncology, John O. Mascarenhas, MD, discussed the phase II findings that demonstrated promising activity with CPI-0610 in a patient population of unmet need.

The FDA’s Oncologic Drugs Advisory Committee will no longer review the supplemental Biologics License Application for luspatercept-aamt for use as treatment of anemia in adult patients with very low- to intermediate-risk myelodysplastic syndromes at the meeting on December 18, 2019.

The triplet regimen of the CXCR4 inhibitor BL-8040, pembrolizumab, plus chemotherapy demonstrated high response and disease control rates in patients with metastatic pancreatic adenocarcinoma, according to preliminary findings from the COMBAT/KEYNOTE-202 trial that were announced in a press release from BioLineRx Ltd, the developer of BL-8040.

In an interview with Targeted Oncology, Mark W. Bustoros, MD, discussed the findings from the study evaluating the genomic predictors of progression in patients with SMM and how these findings will impact treatment decisions for these patients in the future.

The FDA Oncologic Drugs Advisory Committee has announced a hearing to discuss a supplemental new drug application for olaparib tablets&nbsp;<a>for the maintenance treatment of adult patients with deleterious or suspected deleterious germline&nbsp;<em>BRCA-</em>mutant metastatic pancreatic adenocarcinoma</a>&nbsp;who have not progressed on first-line platinum-based chemotherapy.

The FDA granted an Investigational Device Exemption approval to the Personal Genome Diagnostics Inc. elio^TM&nbsp;tissue complete assay for use in a Merck trial evaluating pembrolizumab combinations in non&ndash;small cell lung cancer, according to a press release from PGDx, developer of the assay.

The FDA has granted a Regenerative Medicine Advanced Therapy designation to ADP-A2M4 for the treatment of patients with synovial sarcoma, according to a press release from Adaptimmune Therapeutics, developers of the agent.

In an interview with&nbsp;Targeted Oncology, Fr&eacute;d&eacute;ric Lehmann, MD, discussed the results for the alloSHRINK trial that were presented at the SITC 34^thAnnual Meeting. The allogenic CAR T-cell therapy, CYAD-101, in association with FOLFOX chemotherapy showed promising antitumor activity in patients with refractory mCRC.

In November 2019, the FDA approved a number of treatments, including acalabrutinib for the treatment of chronic lymphocytic leukemia and small lymphocytic leukemia, as well as zanubrutinib for the treatment of mantle cell lymphoma. A biosimilar for pegfilgrastim was also approved under indications.

Following the FDA&rsquo;S approval of gilteritinib in November 2018, adult patients with FLT3-mutant acute myeloid leukemia were able to receive the FLT3 tyrosine kinase inhibitor when they relapsed or became refractory to a prior therapy. The agent has demonstrated promising efficacy in the population of patients with AML harboring FLT3 mutations.

In an interview with&nbsp;Targeted Oncology, Pavlos Msaouel, MD, PhD, discussed the findings from the trial evaluating sitravatinib plus nivolumab in patients with advanced/metastatic urothelial carcinoma. He also highlighted the next steps for this combination regimen.

The FDA has granted a priority review designation to a New Drug Application for pemigatinib, as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, according to a press release from Incyte.

In an interview with Targeted Oncology, Chul Kim, MD, MPH, discussed the results from the phase I/II trial evaluating the combination of an EGFR TKI and Src inhibitor in&nbsp;<em>EGFR</em>-mutant NSCLC. He also highlighted other important advances in the treatment of lung cancer, including the evolving role of circulating tumor DNA to detect disease progression.

In an interview with Targeted Oncology, Partow Kebriaei, MD, discussed the role of transplantation in patients with ALL following treatment with targeted cellular therapies, such as CAR T-cell therapy. She highlights the patient population that receives the most benefit from the use of CAR T-cell therapy and when transplant should be considered for these patients.

In an interview with <em>Targeted Oncology</em>, Lalit Sehgal, PhD, discussed the rationale for investigating how the tumor microenvironment impacts survival in patients with mantle cell lymphoma through various signaling pathways.&nbsp;