Roche’s immunotherapy lucky streak ends with deaths in trial
pharmafile | April 13, 2018 | News story | Medical Communications, Research and Development | Exelixis, Roche, biotech, drugs, pharma, pharmaceutical, tecentriq
Roche’s Tecentriq had begun to show signs of reviving its hopes in the competitive PD-1/L1 market, succeeding in two Phase 3 trials in lung cancer and receiving a NICE approval.
A drug’s work is never done when it comes to snagging more indications but Roche have hit a stumbling block in metastatic colorectal cancer (mCRC), after four patient deaths in a trial.
The Phase 2 was looking into the potential combination treatment of Tecentriq alongside Exelixis’ Cotellic as a first-line treatment. However, after the patient deaths, recruitment for this particular trial has been halted whilst the companies investigate the reasons.
Roche revealed that two of the deaths were due to disease progression and another was definitely ruled out as unrelated to the treatment; however, one death was identified as being as a result of cardiotoxicity and was linked to the treatment.
Roche stated, “The IDMC recommendation followed an observed imbalance in the number of deaths in the experimental arm versus the control arm. At the time of the IDMC review, three deaths occurred on the experimental arm. One death due to cardiogenic shock was treatment related, while the other two deaths were due to disease progression. We recently learned of another death in the Cohort 4 experimental arm, which was documented as not related to study treatment. We are proactively providing the latest information on all the cases to the IDMC.”
Exelixis confirmed that the recruitment halt was only temporary, which would allow the data monitoring committee to question the cause of death.
Roche confirmed that no new safety issues were observed during the trial and that other trials on-going featuring the combination would not be affected.
Phase 3 results from looking at the combination in third-line treatment of mCRC are expected to be due out any point.
Shares in Exelixis took a brief knock after the news, before recovering to be $20.90 only just down on its previous price of $21.32; Roche’s share price remained undisturbed.
Ben Hargreaves
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