News

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.

A Biologics License Application for the investigational chimeric antigen receptor T-cell therapy agent, KTE-X19 has been submitted to the FDA for the treatment of adult patients with relapsed/refractory mantle cell lymphoma, according to a press release from Kite.<br /> &nbsp;

Cancer has historically been divided between localized and metastatic disease. The underlying principle, derived from the Halsted theory of cancer progression, is that once cancer has spread to other sites, it is a systemic disease. Heroic efforts to remove or ablate all evidence of visible cancer thus would expose patients to toxicity without a chance for benefit.

A retrospective study has shown that only 40% of patients with metastatic colorectal cancer received biomarker testing prior to treatment, as recommended in the National Comprehensive Cancer Network guidelines. As a result, patients receive less effective therapies and experience serious adverse events, according to a press release from Guardant Health.

The phase III BELLINI trial demonstrated translocation 11;14 and high&nbsp;BCL2&nbsp;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&nbsp;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.

Zotiraciclib has been granted Orphan Drug Designation by the FDA for the treatment of patients with glioblastoma, according to a press release from Adastra Pharmaceuticals, Inc.

&nbsp;In a&nbsp;<em>Targeted Oncology&nbsp;</em>case-based peer perspectives live discussion with a group of physicians, C. Ola Landgren, MD, PhD, reviewed several combination regimens used in the treatment of multiple myeloma. Landgren, chief of the Myeloma Service at Memorial Sloan Kettering Cancer Center in New York, used the case of a 51-year-old man with standard-risk disease to highlight the benefits and drawbacks of each therapy strategy.

In an interview with&nbsp;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&nbsp;International Myeloma Workshop.

In the phase III CANDOR trial, the addition of daratumumab to carfilzomib and dexamethasone reduced the risk of disease progression or death by 37% compared with carfilzomib and dexamethasone alone in patients with relapsed/refractory multiple myeloma, according to findings from the phase III CANDOR trial presented at the 2019<br /> American Society of Hematology Annual Meeting.

Patients with relapsed/refractory mantle cell lymphoma experienced a 67% complete remission rate and an objective response rate of 93% after treatment with the anti-CD19 CAR T-cell therapy KTE-X19, according to findings from the phase II ZUMA-2 study presented at the 2019 American Society of Hematology ASH Annual Meeting.

The new phase III MOMENTUM clinical trial, which is evaluating the efficacy of momelotinib, a JAK1, JAK2 and ACVR1 inhibitor, versus active comparator danazol in patients with symptomatic and anemic myelofibrosis, was recently launched globally, according to a press release from Sierra Oncology.

A prospective trial showed that treatment with ibrutinib might prompt a decrease in &nbsp;progression-free survival in patients with relapsed or refractory mantle cell lymphoma, according to long-term follow-up data presented at the 2019 American Society for Hematology Annual Meeting and Exposition.

Data from the&nbsp;phase Ib/II CARTITUDE-1 trial that were presented at the 2019 ASH Annual Meeting demonstrated the anti-BCMA CAR T-cell therapy JNJ-4528 achieved a 100% overall response rate with responses in 29 patients with heavily pretreated relapsed/refractory multiple myeloma.<br /> &nbsp;

The FDA&rsquo;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&nbsp;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.

As cancer therapies have evolved and individualized treatments have de-veloped over time, patient-centered care has become more prevalent, and oncology teams must consider it to maximize the chances of positive patient outcomes.

Hodgkin lymphoma represents approximately 10% of all cases of malignant lymphoma. This group of diseases most commonly affects adolescent and young adults, although approximately 20% to 25% of patients are aged &ge;60 years at diagnosis.

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.

Lenvatinib is now indicated for the treatment of differentiated thyroid cancer in China as a result of application acceptance by the National Medical Products Administration of China, according to a press release from Eisai Co., Ltd.<br /> &nbsp;

When treatment decisions are being made regarding chronic lymphocytic leukemia (CLL), patient age should be an important factor. CLL is a disease of the elderly, with more than 40% of all patients &gt;75 years.

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.

Onvansertib inhibits tumor growth in patients with acute myeloid leukemia who are resistant to venetoclax, according to the in-vitro and in-vivo data from a phase II trial announced in a press release issued by Trovagene, Inc.

An Investigational New Drug application for chimeric antigen receptor-T cell agent, ICTCAR014, has been cleared by the FDA for treatment of patients with relapsed/refractory non-Hodgkin lymphoma, including those with PD-L1-positive tumors, according to a press release from Innovative Cellular Therapeutics.

New results from the FLAURA trial have shown that patients with treatment-na&iuml;ve, EGFR&nbsp;mutation&ndash;positive advanced non&ndash;small-cell lung cancer who received first-line osimertinib experienced improved overall survival compared with patients who received either gefitinib or erlotinib.

Abatacept has been granted a Breakthrough Therapy Designation by the FDA for the prevention of moderate to severe acute graft-versus-host disease in hematopoietic stem cell transplants from unrelated donors.

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.

The FDA has approved the combination of atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy for the treatment of patients with metastatic nonsquamous non&ndash;small cell lung cancer, according to a press release from Genentech USA, Inc.<br /> &nbsp;