New research on oncology is creating new knowledge in several areas of therapy. This year is characterized by the successive introduction of several biological agents for the treatment of life-threatening cancer. There’s a big market now for new treatments.
What does the New research in oncology reveal?
Maintenance Daratumumab May Improve Outcomes vs Observation in Patients With Multiple Myeloma
“Among patients with newly diagnosed multiple myeloma, maintenance daratumumab after autologous stem cell transplant (ASCT) appears to significantly improve progression-free survival (PFS) compared with observation alone, according to research published in The Lancet Oncology.
The randomized phase 3 CASSIOPEIA trial (ClinicalTrials.gov Identifier: NCT02541383) previously demonstrated that a daratumumab, bortezomib, thalidomide, and dexamethasone (D-VTd) induction and conditioning regimen improves both depths of response and PFS compared with bortezomib, thalidomide, and dexamethasone (VTd) among patients with transplant-eligible multiple myeloma. In this second part of CASSIOPEIA, researchers evaluated whether maintenance daratumumab yields improved outcomes vs observation only.1
FDA Approves Fyarro (sirolimus protein-bound particles) for the Treatment of Malignant Perivascular Epithelioid Cell Tumor (PEComa)
Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa, an ultra-rare and aggressive form of sarcoma with a strong female predominance.
LOS ANGELES, Nov. 23, 2021 (GLOBE NEWSWIRE) — Aadi Bioscience, Inc. (“Aadi”) (Nasdaq: AADI), a biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, announced that the U.S. Food and Drug Administration (FDA) has approved Fyarro™ (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).2
Nykode Therapeutics in agreement with Regeneron develops innovative vaccines against cancer and infectious diseases
Nykode Therapeutics (formerly Vaccibody), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, announced that it has entered into a license and collaboration agreement with Regeneron for the discovery, development, and commercialization of potential new vaccines for cancer and infectious diseases.3
Transgene, NEC announces positive data from phase I studies of TG4050, a novel individualized neoantigen cancer vaccine
Transgene, a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation, a leader in IT, network and AI technologies, announce positive preliminary immunogenicity and clinical data on TG4050, their jointly developed individualized neoantigen cancer vaccine.4
Cleveland Clinic expands advanced genomic testing platform as the standard of care to patients with cancer
In order to better understand a patient’s cancer and identify potential therapeutic targets, a top American hospital, Cleveland Clinic now offers an advanced genomic testing platform as the standard of care to patients with cancer.
This expanded capability to test tumor samples involves whole-exome sequencing, which examines all the portions of DNA in the genes that are responsible for making proteins in the body, and RNA sequencing that assesses how these proteins are encoded. This combination provides a comprehensive snapshot of the defects that may drive cancer growth. Clinicians can connect patients with individualized treatment aimed at those defects in hopes of improving clinical outcomes and quality of life.5
Biovica begins TK IMPACT study of blood-based biomarker assay DiviTum TKa at Washington University of St Louis
Biovica, active in cancer diagnostics, announces initiation of the TK IMPACT study, an investigator initiated prospective clinical trial at Washington University of St Louis to evaluate the clinical utility of Biovica’s blood-based biomarker assay DiviTum TKa on monitoring practices in the care of metastatic breast cancer patients.The study hypothesis is that incorporation of data from DiviTum TKa measurements into the treatment monitoring of patients receiving standard first-line treatment with CDK 4/6 inhibitors plus endocrine therapies will be associated with the physicians’ decision to change usage and/or timing of other routine monitoring tests such as CT scans and nuclear medicine exams. The study will examine care overtime of 55 patients that will be tested regularly with DiviTum TKa.6
FDA halts phase 1b Kura Oncology trial in acute myeloid leukemia following patient death
The FDA sidelined an early-stage cancer trial from Kura Oncology after a patient died due to a serious adverse event related to the oral treatment’s mechanism of action.
The partial clinical hold means no additional patients in the acute myeloid leukemia trial will be enrolled until the FDA gives the green light. The regulator’s information request is “not complicated,” and the hold should be “relatively short,” Kura’s management said in a conference call Wednesday morning.
The patient’s death in the phase 1b trial is potentially associated with differentiation syndrome, the biotech said. The adverse event is a drug reaction caused by differentiating agents in certain treatments for AML and occurs in up to one-quarter of patients treated with such agents. The syndrome is marked by unexplained fever, acute kidney injury, hypotension, weight gain, and other harmful results.7
Cytovation begins patient dosing in phase I/IIa CICILIA trial of CyPep-1 in combo with Keytruda in patients with a range of solid tumors
Cytovation AS, a clinical-stage immune-oncology company, announces that the first patient has been dosed in the expansion phase of its phase I/IIa CICILIA clinical trial. In this phase of the trial, CyPep-1 is being administered in combination with Keytruda (pembrolizumab) in patients with a range of solid tumors.
Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: “We are very pleased to report the dosing of our first patient with CyPep-1 in combination with MSD’s leading anti-PD-1 therapy Keytruda. This marks a further important milestone in our journey to bring this exciting potential new therapy to patients, where preclinical data suggest that its mode of action is highly synergistic with checkpoint inhibitors. We believe that CyPep-1 could have broad utility in treating a range of solid tumors and we look forward to reporting further data as we progress this study.8
Zydus Cadila receives US FDA approval to market nelarabine injection
Zydus Cadila has received final approval from the US FDA to market nelarabine injection 250MG/50ML in the United States.
Zydus Pharmaceuticals USA Inc was granted a Competitive Generic Therapy (CGT) designation for nelarabine injection, 250 mg/50 mL (5 mg/mL), single-dose vial.9
Natco Pharma launches Tipanat tabs in India to treat advanced colorectal and gastric cancer
Natco Pharma Limited has launched a novel fixed-dose combination of trifluridine + tipiracil for the first time in India under the brand name Tipanat as a pack of 20 tablets in a bottle.
Tipanat is of high importance in not only extending survival but also in preserving the quality of life in the late lines of treatment, which is currently an unmet medical need. Natco has offered Tipanat at an affordable price.
Tipanat is a novel antineoplastic nucleoside analog indicated for the treatment of advanced colorectal and gastric cancer.10