ASCO 2021 | Updated data on subcutaneous teclistamab in R/R myeloma
Saad Usmani, MD, MBBS, MBA, Levine Cancer Institute and Atrium Health, Charlotte, NC, gives an update on the first-in-human Phase I study (NCT04557098) of teclistamab in patients with relapsed/refractory (R/R) multiple myeloma. Dr Usmani shares updated data on the recommended phase 2 dose (RP2D) administered subcutaneously, including measurable residual disease results, and highlights promising efficacy and tolerability findings. Dr Usmani also outlines the efficacy results and discusses the management of side effects. This interview took place at the virtual European Hematology Association (EHA) Congress 2021.
Transcript (edited for clarity)
Certainly, the teclistamab Phase I clinical trials data is being updated by my colleague, Amrita Krishnan, and teclistamab is a BCMA-directed bispecific antibody. It’s an off-the-shelf, full-size bispecific antibody. We have shared the original data with the IV dosing about a year ago for the first time, and now the data being updated for the subcutaneous formulation with the recommended Phase II dosing...
Certainly, the teclistamab Phase I clinical trials data is being updated by my colleague, Amrita Krishnan, and teclistamab is a BCMA-directed bispecific antibody. It’s an off-the-shelf, full-size bispecific antibody. We have shared the original data with the IV dosing about a year ago for the first time, and now the data being updated for the subcutaneous formulation with the recommended Phase II dosing.
And the patients that have been treated with that dose are 40 in total. And they have a median of five prior lines of treatment. Vast majority of patients are triple-class refractory. About 40% are penta-drug refractory and 83% were refractory to the previous line of treatment.
And what we’re seeing is CRS in maybe about 60 to 70% of the patients, but all are grade one and two, and very manageable. Low rates of grade one and two injection site reactions or erythema, but really beyond the as expected hematologic side-effects, we’re not seeing much in terms of other side-effects. For the most part, CRS is very well managed with supportive care measures using tocilizumab, steroids.
The overall response rate for this patient population at the recommended Phase II dose is 65% with VGPR or better in 58% of the patients. And the median time to first confirmed response is about a month. The overall response rate in the triple-class refractory patients is 61%. So, quite impressive. And the recommended Phase II dose, even though these are lower numbers. And then of the evaluable patients, there were six who were evaluable for MRD, of them, five were MRD-negative at 10 to the minus six and one at 10 to the minus five.
And then with subsequent follow-up, median follow-up of about 7.1 months, 22 of the 26 patients who responded are alive and continuing on therapy. So, you know, the summary of the update is that the subcutaneous formulation of teclistamab at 1500 micrograms per kilogram, appears to be well-tolerated without any new safety signals, low-grade CRS, very manageable and overall response rate of 65%. And in triple-class refractory patients, it’s 61%. So, the dose expansion is ongoing as well as combination trials, in earlier lines of treatment.
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Disclosures
Saad Usmani, MD, MBBS, MBA, has received research funding from Amgen, Array Biopharma, BMS, Celgene, GSK, Janssen, Merck, Pharmacyclics, Sanofi, Seattle Genetics, SkylineDX, Takeda; has received consulting fees from Abbvie, Amgen, BMS, Celgene, GSK, Genentech/Roche, Janssen, Karyopharm, Merck, Oncopeptides, Sanofi, Seattle Genetics, SkylineDx, Takeda; and has received speaking fees from Celgene, Janssen, Sanofi, Takeda.
