Clinical Catch-Up: June 1-6
With the 2021 American Society of Clinical Oncology meeting held late last week, there is plenty of clinical trial news. It’s not possible to cover all of ASCO in this column, and there were other meetings and announcements last week as well, but here are some highlights. Take a look.
The National Institutes of Health (NIH) launched an early-stage trial to test mixing COVID-19 booster vaccines in fully vaccinated adults. The project is trying to understand the safety and immune responses after mixed boosted shots, should booster vaccines be necessary. The National Institute of Allergy and Infectious Diseases (NIAID)-funded trial involves about 150 people who already received one of the vaccines authorized in the U.S., Pfizer-BioNTech, Moderna, or Johnson & Johnson.
Morphic Therapeutic presented new Phase I data for MORF-057 for inflammatory bowel disease (IBD). The data confirmed the tolerability and pharmacodynamic profile from the initial MORF-057 SAD data, which was well-tolerated. MORF-057 is a selective, oral small molecule inhibitor of the alpha4beta7 integrin, and is designed to block interactions between alpha4beta7 on the surface of lymphocytes and the mucosal endothelial cell ligand MAdCAM-1.
Sequana Medical enrolled the first patient in the SAHARA DESERT study of alfapump DSR in heart failure patients with persistent congestion. Alfapump DSR combines DSR therapy, which removes sodium from the body using diffusion in the peritoneal cavity, with the use of a sodium-free solution called DSR infusate, and the company’s alfapump fully implanted system.
Janssen Pharmaceutical of Johnson & Johnson presented more than 30 studied at ASCO, including data on the ongoing CHRYSALIS study of Rybrevant in combination with Lazertinib in non-small cell lung cancer; new Cilta-Cel data in r/r multiple myeloma from the Phase Ib/II CARTITUDE-1 and -2 studies; Phase I and II data for bispecific antibodies talquetamab and teclistamab in r/r multiple myeloma; first data from the CAPTIVATE study of Imbruvica (brutinib) in combination with venetoclax for first-line chronic lymphocyte leukemia; and much more.
Novartis announced the results of the Phase III VISION trial of 117Lu-PSMA-617, a targeted radioligand therapy and standard of care, which demonstrated significant improvement in OS compared to SOC alone in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer. They also presented overall survival analysis from MONALEESA-3 of Kisqali (ribociclib) for HR+/HER2- advanced breast cancer; long-term disease control in patients with PIK3CA-altered advanced breast cancer treated with alpelisib and fulvestrant and others. Novartis also presented data from the primary analysis of the Phase II ELARA trial of Kymriah (tisagenlecleucel) in r/r follicular lymphoma (FL). There was a 66% CR, 86% ORR, with median DOR in all responders, PFS and OS were not reached.
Ultimovacs published data from the ongoing NIPU Phase II trial of its universal cancer vaccine, UV1, in malignant pleural mesothelioma (MPM). The study outlines the mechanistic rationale for the use of UV1 with two checkpoint inhibitors, ipilimumab and nivolumab.
Brickell Biotech announced results from the Phase III long-term safety and efficacy study in Japan by development partners, Kaken Pharmaceutical Co., for sofpironium bromide gel (Ecclock). The study is for primary axillary hyperhidrosis, a debilitating, life-altering condition where a person sweats beyond what is needed for thermoregulation.
Intensity Therapeutics presented Phase I/II data from its ongoing study of INT230-6 in refractory and relapsed metastatic solid tumors. INT230-6 is made up of cisplatin and vinblastine, as well as a penetration enhancer molecule to help disperse the drugs throughout tumors.
ImmVira presented data from its Phase I trial of MVR-T3011 in advanced solid tumors. The drug is a next-generation, genetically modified oncolytic herpes simplex virus.
CBMG Holdings presented Phase I data of C-CAR066 in patients with r/r B-NHL previously treated with anti-CD19 CAR-T therapy. C-CAR066 is a novel second-generation CAR-T that targets CD20.
SALVAT completed the Phase III trials in the U.S. of its new ophthalmic corticosteroid nanoemulsion for ocular inflammation and pain after cataract surgery. Analyses are expected in the second half of the year with the possibility of regulatory submissions by the end of the year.
Impel NeuroPharma presented pivotal Phase III data from the STOP-301 study of INP104. INP104 is dihydroergotamine mesylate (DHE) delivered directly into the upper nasal space using the company’s proprietary Precision Olfactory Delivery (POD) technology. The study was for acute treatment of migraine.
Gilead Sciences/Kite presented results from the Phase I/II ZUMA-3 trial of KTE-X19 in adults with r/r B-acute lymphocytic leukemia. KTE-X19 is an autologous anti-CD19 CAR-T therapy. The company indicated the results at the recommended Phase II dose were encouraging, which are what they presented.
UCB presented new data for its Fc-free anti-TNF, Cymzia (certolizumab pegol) and its investigational IL-17A and IL-17F inhibitor, bimekizumab. The e-posters included new Phase IIb data from the BE AGILE and BE ACTIVE open-label extension studies looking at the long-term safety and efficacy of bimekizumab in patients with ankylosing spondylitis (AS) and psoriatic arthritis, respectively.
Arcus Biosciences presented initial efficacy and safety data from one of the cohorts in its Phase Ib/II ARC-6 study of etrumadenant and zimberelimab and docetaxel in people with taxane-naïve metastatic castrate-resistant prostate cancer who progressed after treatment with one or more new hormonal agents and were checkpoint inhibitor-naïve. Etrumadenant is a dual adenosine A2A/A2b receptor antagonist. Zimberelimab is an anti-PD1 checkpoint inhibitor.
Centogene initiated the observational EFRONT study with support from Alector. The study will enroll and genetically test more than 3,000 patients with frontotemporal dementia at sites in Belgium, Germany, Greece, Italy, Portugal, Spain, and Turkey.
AbbVie presented 23 abstracts and four podium presentations at the 2021 American Headache Society (AHS) Annual Meeting over a range of studies from its migraine portfolio. The presentations include findings on atogepant, the company’s investigational preventive treatment for migraine as well as data on Ubrelvy (ubogepant) and Botox (onabotulinumtoxinA).
Vincerx Pharma dosed the first patient in its Phase Ib trial of VIP152 in MYC-driven r/r aggressive lymphomas and advanced solid tumors. Arm 1 will enroll up to 30 patients with r/r aggressive lymphoma, including DLBCL, transformed follicular lymphoma, and blastoid mantle cell lymphoma. Arm 2 will enroll up to 40 patients with advanced solid tumors, including ovarian, triple-negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration.
Bristol Myers Squibb presented data from the Phase III CheckMate -648 trial. There were two combinations, Opdivo (nivolumab) plus chemotherapy and Opdivo plus Yervoy (ipilimumab). Both demonstrated statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy at the interim analysis in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression greater than or equal to 1%, as well as in the all-randomized population.
Nanobiotix presented results from its first-in-class radioenhancer NBTXR3 in combination with an anti-PD-1 checkpoint inhibitor, which converted patients who did not respond to checkpoint inhibitors into responders. The objective response was 60% in anti-PD-1 naive patients and 50% of previous non-responders. So far, the overall adverse event profile for the 16 patients is no different that was is expected with radiotherapy or checkpoint inhibitors. The primary tumors investigated were for head and neck cancer and non-small cell lung cancer.
Surface Oncology and Roche are partnering to evaluate SRF388, Surface’s anti-IL-27 antibody, in combination with Roche’s atezolizumab and bevacizumab in treatment-naïve hepatocellular carcinoma. SRF388 is a fully human anti-IL-27 antibody that inhibits the activity of this immunosuppressive cytokine.
Sanofi partnered with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and Alliance Foundation Trials (AFT) to collaborate on the Phase III AMEERA-6 study. It will test its amcenestrant in estrogen receptor-positive (ER+) patients against tamoxifen.
G1 Therapeutics presented data from its Phase I trial of rintodestrant. The drug is an oral selective estrogen receptor degrader (SERD). The drug was well tolerated and did not add toxicities when added to Palbociclib for treatment of ER+/HER2- advanced breast cancer.
SQZ Biotech presented initial data from its ongoing Phase I trial of SQZ-PBMC-HPV for advanced or metastatic HPV16+ tumors. The data shows the cell therapy is safe and well-tolerated and can stimulate immune responses in certain patients.