Current accepted of delight in evolved head and neck squamous cell carcinoma includes the anti-PD-1 checkpoint inhibitor pembrolizumab (Keytruda) with or without chemotherapy (platinum/5-fluorouracil [5-FU]). The INDUCE-1 trial — led by Erminia Massarelli, MD, PhD, a thoracic oncology specialist at City of Hope in Duarte, California — examined the addition of the ICOS-1 antibody GSK609 to these regimens.
On this weird MedPage Nowadays video, Massarelli discusses the trial’s safety results that she equipped at the 2020 American Society of Scientific Oncology virtual scientific assembly.
Following is a transcript of her remarks:
The background of our trial is de facto, if we can even compose better the efficacy of pembrolizumab plus chemotherapy in sufferers with head and neck squamous cell carcinoma with PD-L1 [expression] lower than 1. And, basically this is a section 1 [trial], the toxicity of the affiliation of ICOS-1 antibody plus pembrolizumab and chemotherapy with platinum (either cisplatin or carboplatin, plus 5-FU). Alternatively, we also equipped every other multi-cohort section 1 clinical trial with pembrolizumab along with chemotherapy — on the entire as adverse to the four-drug regimen, the three-drug regimen, so the ICOS plus the cisplatin or carboplatin plus 5-FU.
So, this is fragment of an even bigger section 1 trial called INDUCE-1, and within the other results of the affiliation of ICOS-1 antibody and pembrolizumab alone luxuriate in already been equipped earlier at other conferences, and shown in actuality to be manageable without important elevated toxicity.
So in our two cohorts of sufferers, we in actuality stumbled on that for the ICOS alone plus chemotherapy or ICOS plus pembrolizumab plus chemotherapy, the toxicity is manageable with indispensable aspect effects that are the same as pembrolizumab immunotherapy plus chemotherapy. And, so we stumbled on that in particular, after we use cisplatin needless to remark now we luxuriate in more cytopenia, in particular neutropenia and neuropathy; after we use carboplatin in actuality, the cytopenias are much less.
We are also presenting in our summary, two important responses of two sufferers. One used to be treated with cisplatin plus 5-FU ICOS, and pembrolizumab; the other one used to be treated with carboplatin plus 5-FU and ICOS and pembrolizumab. Both had important responses, nearly total responses that lasted no lower than 6 months.
So we on the entire concluded that the addition of ICOS-1 antibody plus the pembrolizumab plus chemotherapy is doable without elevated important toxicity. And we are already planning to circulate it forward proper into a section II/III randomized trial in first-line, metastatic head and neck cancer, that will be called INDUCE-4. And this can even inaugurate occurring by the head of 2020.