News

In an interview with Targeted Oncology at the 2019 ASH Annual Meeting, Diego Villa, MD, MPH, discussed the benefit of bendamustine plus rituximab versus R-CHOP in transplant-eligible and -ineligible patients with mantle cell lymphoma.

A fixed-dose subcutaneous formulation of pertuzumab and trastuzumab in combination with intravenous chemotherapy has been accepted by the FDA for the treatment of eligible patients with HER2-positive breast cancer, which is supported by results of the phase III FeDeriCa study.

Researchers at the Fox Chase Center have identified MRCKA, a serine/threonine-protein kinase, as a target for treating high-grade serous ovarian carcinoma, the most lethal of gynecologic malignancies, for which few targeted therapies exist. The research was recently published in Science Signaling, Fox Chase announced in a press release.

Although the novel combination of cabiralizumab and nivolumab with or without the addition of chemotherapy induced an intriguing response rate in previous phase I data as a treatment for patients with advanced pancreatic cancer, the phase II clinical trial did not meet its primary end point of progression-free survival, according to a press release from Five Prime Therapeutics.

In an interview with Targeted Oncology, Stephen J. Schuster, MD, discussed the findings for mosunetuzumab in patients with relapsed/refractory non-Hodgkin lymphoma and the particularly promising findings for those patients who had received prior chimeric antigen receptor T-cell therapy.

In a <em>Targeted Oncology</em>&trade; case-based peer perspective live discussion, Sandip P. Patel, MD, associate professor of medicine at the University of California San Diego Health, discussed EGFR inhibition options for patients with non&ndash;small cell lung cancer, based on the case of a real patient.

Clinically meaningful outcomes in patients with chronic graft-versus-host disease were observed with administration of the selective ROCK2 inhibitor KD025, according to interim results of the phase II ROCKstar trial presented at the 2020 Transplant and Cellular Therapies Meetings in Orlando, Florida.

In an interview with&nbsp;Targeted Oncology, Kellie Ryan, MPH, discussed the data on how physicians are currently using acalabrutinib as treatment of patients with mantle cell lymphoma in the real-world setting. She highlighted where she sees this research evolving in time.

The FDA has granted Priority Review to the New Drug Application for brigatinib as first-line treatment for patients with ALK-positive metastatic non&ndash;small cell lung cancer as detected by an FDA-approved test, Takeda Pharmaceutical Company announced in a press release.

Combining the antibody-drug conjugate polatuzumab vedotin with bendamustine and rituximab resulted in a significantly higher complete response rate in patients with transplantation-ineligible relapsed/refractory diffuse large B-cell lymphoma compared with patients who received BR alone. The international, multicenter, open-label, phase Ib/II trial also found that pola-BR reduced the risk of death by 58%, according to a recent Journal of Clinical Oncology paper.

In the CheckMate 025 trial, nivolumab remained superior to everolimus in terms of efficacy and safety in patients with advanced renal cell carcinoma at more than 5 years minimum follow-up and had continued responses in 28 percent of patients, according to a presentation at the 2020 American Society of Clinical Oncology Genitourinary Cancers Symposium.

Treatment with immune checkpoint inhibitors appears to elicit limited clinical activity in patients with osteosarcoma. In a study, investigators at MD Anderson Cancer Center found that certain factors like poor infiltration of the tumor by immune cells, low activity from available T cells, a lack of immune-stimulating neoantigens, and multiple immune-suppressing pathways may interfere with response to immunotherapy in these patients, according to a press release from the organization.<br /> &nbsp;

Preliminary results from a safety and tolerability phase I/II study signal promise for ADXS-503 alone and in combination with pembrolizumab as treatment of patients with metastatic squamous and non-squamous non&ndash;small cell lung cancer, Advaxis, Inc, announced in a press release. Findings were presented during the International Association for the Study of Lung Cancer 2020 Targeted Therapies of Lung Cancer Meeting, February 19-22, 2020, in Santa Monica, California.

Preliminary results of the phase III SIERRA trial indicate that conditioning therapy with iodine apamistamab leads to high rates of allogeneic hematopoietic stem cell transplant in patients with active acute myeloid leukemia, according to Boglarka Gyurkocza, MD, who presented midpoint results of the trial at the 2020 Transplant &amp; Cellular Therapies Meeting in Orlando, Florida.

A Priority Review supplemental New Drug Application for selinexor, a selective inhibitor of nuclear export, has been accepted for filing by the FDA, according to the manufacturer, Karyopharm Therapeutics, Inc, in a press release.&nbsp;The application seeks accelerated approval from the agency as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.

The FDA has granted Breakthrough Therapy Designation to enfortumab vedotin plus pembrolizumab for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.

In the phase II CLOVER-1 trial, the small-molecule phospholipid drug conjugate CLR 131, achieved high response rates in patients with relapsed/refractory multiple myeloma and relapsed/refractory non-Hodgkin lymphoma, meeting the primary efficacy end point of the study, according to a press release from Cellectar Biosciences, developer of the agent.

The FDA has granted Priority Review to the supplemental Biologic License Application for atezolizumab as first-line treatment of patients with advanced non-squamous and squamous non-small cell lung cancer without&nbsp;EGFR&nbsp;or&nbsp;ALK&nbsp;mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.&nbsp;

Plinabulin in combination with docetaxel, doxorubicin, cyclophosphamide, and pegfilgrastim led to a dose-dependent increase in mean haptoglobin and absolute neutrophil count, demonstrating potency in the stimulation of the adaptive and innate immune system following previous positive efficacy and safety results, according to data analyzed from the phase III BPI-2358-106 study presented at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium.

In an interview with <em>Targeted Oncology</em>, Rajneesh Nath, MD, discussed the background and rationale for the phase III SIERRA trial. He also explained what this research means for the treatment landscape of acute myeloid leukemia.&nbsp;

The FDA has granted Fast Track Designation to ALX148 for the first-line treatment of patients with head and neck squamous cell carcinoma, and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction carcinoma.

In an interview with Targeted Oncology, Jason Westin, MD, discussed findings from a correlative analysis of the cytokine release syndrome and neurotoxicity associated with the chimeric antigen receptor T-cell therapy in the JULIET trial. He highlighted other important takeaways on the data on chimeric antigen receptor cells in diffuse large b-cell lymphoma.

The FDA has granted Priority Review to the New Drug Application for lurbinectedin, which is being considered for accelerated approval as a treatment of patients with small cell lung cancer who have progressed after prior platinum-containing therapy.

Combining cabozantinib plus androgen-deprivation therapy as first-line therapy in patients with hormone-na&iuml;ve metastatic prostate cancer yields promising clinical activity, according to the new single-arm phase II study, which was published in Clinical Cancer Research.

Pepinemab plus avelumab has shown initial signals of antitumor activity and is well tolerated in patients with advanced non&ndash;small cell lung cancer, according to an interim analysis of the CLASSICAL-Lung phase Ib/II clinical trial presented at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium in Orlando, Florida.

The FDA has granted Priority Review to the New Drug Application for tazemetostat as treatment for patients with relapsed or refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy. The drug will now be considered for accelerated approval and the application was designation as a supplemental NDA with a Prescription Drug User Fee Act target action date of June 18, 2020, Epizyme, Inc announced in a press release.

The first-in-class AXL inhibitor bemcentinib plus checkpoint inhibitor pembrolizumab induced promising activity in patients with non&ndash;small cell lung cancer regardless of PD-L1 status, according to a phase II clinical trial. The data also suggest a greater benefit with the combination in patients who are AXL-positive.<br /> &nbsp;

The FDA has granted Priority Review to the New Drug Application for the combination of tucatinib, trastuzumab, and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The prescription Drug User Fee Act, the FDA has set a target action date of August 20, 2020.&nbsp;

The FDA has granted Priority Review to the Biologics License Application for lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, after at least 2 prior therapies.

The FDA has granted Priority Review to the New Drug Application for ripretinib as treatment of patients with advanced gastrointestinal stromal tumors. This potential FDA approval has a Prescription Drug User Fee Act target action date of August 13, 2020, according to a press release from Deciphera Pharmaceuticals, Inc.<br /> &nbsp;