Lynne Peterson is the Senior Editor for Trends-in-Medicine.
Here is the medical news to watch for December 6-12, 2021.
Cardiology: The EuroEcho meeting, taking place only virtually December 9-11, will highlight the latest developments in cardiovascular imaging—from gender differences to long Covid, machine learning to predict mortality, the impact of weight loss after bariatric surgery, novel imaging methods to assess cardiotoxicity, and much more.
Gynecology: The FDA is expected to make a decision by December 7 on Daré Bioscience’s DARE-BV1, a thermosetting bioadhesive hydrogel containing clindamycin phosphate 2%, as a one-time vaginally-administered treatment for bacterial vaginosis.
Nephrology: The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet virtually on December 8 to consider Reata Pharmaceuticals’ bardoxolone methyl, an Nrf2 activator, for slowing chronic kidney disease (CKD) in Alport syndrome patients.
- The hybrid American Epilepsy Society (AES) meeting is continuing through December 7. Among the data to watch on those last two days are:
- The results of the VIOLET trial of Marinus Pharmaceuticals’ ganaxolone, a GABAA receptor modulator, for PCDH19-related epilepsy.
- SK Biopharmaceuticals’ XCOPRI (cenobamate) for focal seizures.
- The FDA’s Neurological Devices Advisory Committee will meet virtually December 10 to consider BrainsGate’s BrainsGate Ischemic Stroke System for increasing cerebral blood flow and reducing disability in acute ischemic stroke patients unable to receive tPA.
- The International Symposium on ALS/MND will take place virtually December 7-10. This is the largest annual meeting on amyotrophic lateral sclerosis and motor neurone disease.
- The hybrid San Antonio Breast Cancer Symposium (SABCS) will take place in San Antonio and virtually December 7-10. In-person attendance is expected to be ~30% of normal. Among the breast cancer data to watch:
- The phase I ACE-Breast-01 and phase II ACE-Breast-03 trials of Ambrx Biopharma’s ARX-788 in HER2+ metastatic breast cancer.
- Phase Ib results for Arvinas’ ARV-471, an oral estrogen receptor degrader, in ER+/HER2-negative breast cancer.
- Phase I results for Context Therapeutics’ onapristone extended-release (ONA-XR), a progesterone receptor antagonist.
- Updated safety and efficacy data from the phase II MARIO-3 trial of Infinity Pharmaceuticals’ eganelisib (IPI-549) + Roche’s Tecentriq (atezolizumab) + nab-paclitaxel and the combination of IPI-549 + atezolizumab + bevacizumab in front-line triple-negative breast cancer (TNBC).
- Phase II HALT-D trial of Jaguar Health/Napo Pharmaceuticals’ Mytesi (crofelemer) to treat cancer-related diarrhea.
- Phase I results for Olema Oncology’s OP-1250, an ER antagonist, in ER+/HER2-negative breast cancer.
- Phase II IRENE trial of Oncolytics Biotech’s pelareorep (an IV reovirus) + Incyte and MacroGenics’ retifanlimab (an anti-PD-1) in TNBC.
- Phase II interim results from the KEYNOTE-890 trial of OncoSec Medical’s TAVO (intratumoral IL-12) + Keytruda (pembrolizumab) in TNBC.
- Phase II SUMMIT trial of Puma Biotechnology’s Nerlynx (neratinib) in solid tumors with somatic HER2 or EGFR exon 18 mutations.
- Phase I results for Zymeworks’ zanidatamab (ZW25), a bispecific antibody, in HER2+ breast cancer.
- The hybrid European Society for Medical Oncology—Immuno-Oncology (ESMO-IO) meeting will take place December 8-11 in Geneva, Switzerland, and virtually. Among the data to watch:
- Phase I results for Adagene’s ADG-106, an anti-CD137 agonist, and ADG-116, an anti-CTLA4.
- Phase I/II results for Affimed’s AFM13 (a bispecific anti-CD16A/CD30) + NK cells in CD30+ lymphomas.
- Phase I results for Atara Biotherapeutics’ ATA-2271, a mesothelin-targeted autologous CAR T, in mesothelioma.
- Phase II results for Innate Pharma’s monalizumab (a humanized anti-NKG2A antibody) + cetuximab in squamous cell carcinoma of the head and neck.
- Phase I results for Merus and Incyte’s MCLA-145, a bispecific CD137/PD-L1 inhibitor, in solid tumors.
- Phase I/II PROPEL trial results for Nektar’s bempegaldesleukin (NKTR-214) + pembrolizumab in solid tumors.
- Preliminary results of a first-in-human dose-escalation phase I/II trial for SQZ Biotechnologies’ SQZ-PBMC-HPV-101, a cell therapy, in solid tumors.
- The hybrid American Society of Hematology (ASH) meeting starts in Atlanta and virtually December 11. Among the data to watch:
- Acute myeloid leukemia (AML): Phase III AGILE trial of Servier/Agios’ Tibsovo (ivosidenib), an IDH1 inhibitor, added to azacitidine.
- Beta-thalassemia: bluebird bio’s betibeglogene autotemcel (beti-cel), a gene therapy.
- Chronic lymphocytic leukemia (CLL): New analyses of the phase III ASCEND trial of AstraZeneca’s Calquence (acalabrutinib).
- Epstein-Barr virus after solid organ transplant: Phase III results for Atara Biotherapeutics’ Tab-cel (tabelecleucel, ATA-129).
- Lymphoma: Data on two CAR T therapies: Gilead Sciences/Kite’s Yescarta (axicabtagene ciloleucel, axi-cel) in ZUMA-7 and Bristol-Myers Squibb/Juno Therapeutics’ Breyanzi (lisocabtagene maraleucel, liso-cel); inMIND trial of Incyte and MorphoSys’ Monjuvi (tafasitamab) + Revlimid (lenalidomide) + Rituxan (rituximab); A 90-patient study of Roche/Genentech’s mosunetuzumab (RG-7828), a T-cell bispecific (anti-CD20/CD3).
- Multiple myeloma: Overall survival results from a phase III trial of AbbVie’s Venclexta (venetoclax), a Bcl-2 inhibitor; and the results of the phase III GMMG-HD7 trial of Sanofi’s Sarclisa (isatuximab) + RVd (lenalidomide + bortezomib + dexamethasone).
- Myelofibrosis: Phase II MANIFEST trial of Constellation Pharmaceuticals’ pelabresib (CPI-0610), a BET inhibitor.
Regulatory: Hearing aids. The FDA is hosting a webinar on December 7 to discuss the Agency’s proposal to allow over-the-counter sale of hearing aids.
Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine
Cat ID: 238
Topic ID: 78,238,730,914,238,332,697,127,130,842,191,192,725,237,331,696,841