Mural Oncology is discontinuing the development of nemvaleukin alfa in ovarian cancer after a Phase III trial failed to improve overall survival (OS) in platinum-resistant ovarian cancer (PROC), prompting a 57% drop in stock value.
The US company announced that it will no longer be proceeding to final analysis of the Phase III trial and the company will cease development of nemvaleukin for PROC.
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In the Artistry-7 trial (NCT05092360) the median OS was 10.1 months for patients treated with nemvaleukin in combination with MSD’s Keytruda (pembrolizumab) and 9.8 months for patients treated with investigator’s choice chemotherapy.
Following the announcement the company’s stock value, listed on the Nasdaq exchange, has dropped more than 60% from $3.83 per share at market close on 24 March, down to $1.53 per share at the time of publication (25 March).
Mural Oncology CEO Caroline Loew said: “We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumour, yet there are still few treatment options that improve survival in this very difficult-to-treat tumour type.
“We are still on track to report topline data from our potentially registrational trial in mucosal melanoma later next quarter and will assess all available data to inform our next steps.”
The trial recruited a total of 456 patients from 117 international locations splitting them into four arms receiving either nemvaleukin, Keytruda, a combination of both or investigator’s choice chemotherapy.
Nemvaleukin is an engineered fusion protein designed to take advantage of the immune system cytokine Interleukin-2 (IL-2) without triggering its associated toxicity.
Research by GlobalData estimates that should nemvaleukin alfa make it to market in other indications, it could generate as much as $255m for the company by the end of the decade.
GlobalData is the parent company of Clinical Trials Arena.
Away from PROC, Mural Oncology is investigating nemvaleukin in mucosal melanoma as part of its Phase II Artistry-6 trial (NCT04830124), with a topline data readout expected before the end of this year.
Elsewhere in the field of ovarian cancer, Innovent Biologics has dosed the first subject in the randomised Phase III HeriCare-Ovarian01 trial of IBI354. Meanwhile, NiKang Therapeutics has concluded the first cohort dosing in the open-label Phase I trial of NKT3964.
