Safety profile of MacroGenics’ vobra duo takes steep downturn
10 May 2024
Clinical ResultPhase 2Phase 3
The safety profile of MacroGenics’ experimental drug vobramitamab duocarmazine (vobra duo) looks to have taken a sharp nosedive after the latest data cut from the ongoing Phase II TAMARACK study revealed five deaths. In contrast, an update provided last month indicated that there were no fatalities in the trial for patients with metastatic castration-resistant prostate cancer (mCRPC).
Shares in the company plunged as much as 62% following the news of the deaths, with MacroGenics noting that two of the fatalities – one from an acute myocardial infarction and the other a case of cardiac arrest – were deemed unrelated to vobra duo. The remaining deaths were attributed to two cases of pneumonitis - possibly treatment-related - and a Grade 3 pleural effusion that is recorded as having a fatal outcome and is being investigated further.
According to the company, one death occurred in the group given the lower dose of vobra duo, while the others were all seen in the higher-dose group. The latest data also showed that 52.8% of patients given vobra duo experienced a Grade ≥3 treatment-emergent adverse event, with 47.2% having to undergo a dose reduction and 13.1% stopping treatment altogether.
In terms of efficacy, results indicated that a confirmed PSA reduction of ≥50% was seen in 43.9% of patients in the low-dose vobra duo group, falling to 36.6% in those given the higher dose. Meanwhile, the confirmed objective response rate (ORR) in the two arms was 17.8% and 25%, respectively. Ahead of the data, BMO Capital Markets analysts said that the base-case scenario for TAMARACK was at least 50% of patients experiencing a PSA reduction of ≥50% and an ORR in the range of 30% to 40%.
Despite the safety concerns, CEO Scott Koenig said “as we view the data right now, both doses are potentially usable and further developable going forward with this interim data.” He added “we have initiated planning activities for a potential Phase III study that could commence next year.”
More to come.
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