VJOncology is committed to improving our service to you

Share this video  

VJOncology is committed to improving our service to you

ASCO 2021 | Phase I/II study of a novel SERCA in ER+ HER2- BC

Erika Hamilton, MD, Sarah Cannon Research Institute, Nashville, TN, discusses the results of a Phase I/II study (NCT03250676) of H3B-6545 for the treatment of estrogen receptor (ER)-positive, HER2-negative advanced breast cancer refractory to endocrine therapy. H3B-6545, a novel selective ERα covalent agonist (SERCA), was assessed in 94 patients with a median of 3 prior lines of therapy. The data obtained to date show H3B-6545 to have a manageable safety profile and promising anti-tumor activity in heavily pretreated patients. A partial response was seen in 17% and 43% had stable disease. Responses were seen in patients who had received prior fulvestrant, CDK4/6 inhibitor, and/or chemotherapy in the metastatic setting, suggesting H3B-6545 could be beneficial option following CDK4/6 inhibition. This interview took place at the American Society of Clinical Oncology (ASCO) 2021 Virtual Meeting.

Transcript (edited for clarity)

This is a twist on endocrine therapy. We’ve heard a lot about SERDs or selective estrogen receptor degraders. This is a SERCA, so a selective estrogen receptor covalent antagonist. And we presented data at ASCO 2021 for 94 patients that were treated at the 450 milligram dose. This was really a heavily pretreated patient population and I encourage everyone to kind of look at the patient characteristics when comparing the SERDs and the SERCAs across studies, because they’re not all quite created equal...

This is a twist on endocrine therapy. We’ve heard a lot about SERDs or selective estrogen receptor degraders. This is a SERCA, so a selective estrogen receptor covalent antagonist. And we presented data at ASCO 2021 for 94 patients that were treated at the 450 milligram dose. This was really a heavily pretreated patient population and I encourage everyone to kind of look at the patient characteristics when comparing the SERDs and the SERCAs across studies, because they’re not all quite created equal. 85% of these patients had seen prior CDK4/6 which as we know is now the standard. 72 or about three quarters of our patients had received a prior fulvestrant. A third of patients had seen more than four lines in the metastatic setting and half of our patients at seen chemotherapy.

And so what we saw with this oral therapy is a median progression of over five months that broke down to 17% of patients having a partial response and 43% of patients having stable disease. For a clinical benefit rate with the more conservative definition of CRs, PRs, plus stable disease of at least six months, duration of 40%. And so I think that we’re going to hear more about SERDs and SERCAs, et cetera, particularly post CDK4/6. Certainly also has the possibility for these agents to go in with CDK4/6 inhibitors. But we know for patients that are highly dependent on estrogen signaling that even post aromatase inhibitor and CDK4/6 we need other very effective drugs in this space.

Read more...

Disclosures

Dr. Hamilton discloses research funding (payable to institution only, no personal funds) from : OncoMed, Genentech/Roche, Zymeworks, Rgenix, ArQule, Clovis, Silverback Therapeutics, Millenium, Acerta Pharma, Sermonix Pharmaceuticals, Torque, Black Diamond, Karyopharm, Infinity Pharmaceuticals, Curis, Syndax, Novartis, Boehringer Ingelheim, Immunomedics, FujiFilm, Taiho, Deciphera, Fochon, Molecular Templates, Onconova Therapeutics, Dana Farber Cancer Hospital, Hutchinson MediPharma, MedImmune, SeaGen, Puma Biotechnology, Compugen, TapImmune, Lilly, Pfizer, H3 Biomedicine, Takeda, Merus, Regeneron, Arvinas, StemCentRx, Verastem, eFFECTOR Therapeutics, CytomX, InventisBio, Lycera, Mersana, Radius Health, Abbvie, Nucana, Leap Therapeutics, Zenith Epigenetics, Harpoon, Orinove, AstraZeneca, Tesaro, Macrogenics, EMD Serono, Daiichi Sankyo, Syros, Sutro, G1 Therapeutics, Merck, PharmaMar, Olema, Polyphor, Immunogen, Plexxicon, Amgen, Akesobio Australia, Shattuck Labs.

Dr. Hamilton discloses consulting/advisory role payments( to institution only, no personal funds accepted) from: Genentech/Roche, Boehringer Ingelheim, Novartis, Dantari, Lilly, Merck, Puma Biotechnology, Silverback Therapeutics, CytomX, Pfizer, Mersana, Black Diamond, H3 Biomedicine, Daiichi Sankyo, AstraZeneca, Arvinas, Deciphera Pharmaceuticals, Eisai, Seagen

Sign-up for our Newsletter!

Keep up to date with all the latest news with our monthly newsletter