Two more stumbles for I-O agents

Chalk up two more defeats in immuno-oncology. Bristol-Myers Squibb today conceded that its confirmatory small-cell lung cancer trial of Opdivo failed to show a survival benefit over chemotherapy, while Immune Design shelved a trial of its cancer vaccine CMB305 in combination with Tecentriq in patients with synovial sarcoma. Opdivo’s lung cancer miss in previously treated patients will once again raise the question of whether the US FDA should withdraw the drug’s accelerated approval in this setting, which it won in August. More readouts with Opdivo in SCLC, in combination with other agents, are due soon, along with data from rivals Keytruda and Imfinzi, while Roche has already reported positive first-line data with Tecentriq (World Lung 2018 – Roche gives rivals a small-cell target to shoot for, September 25, 2018). For Immune Design, the CMB305 decision was made after an ad hoc review of the Synovate trial that indicated the combo with Tecentriq would not yield a survival benefit in relapsed patients. The group said it would prioritise its TLR4 agonist G100 instead, allowing it to extend its cash runway another six months, into 2021. Shares fell 41% in early trading today.

Confirmatory PD-(L)1 trials that have failed
Company Drug Setting Trial Date
Roche Tecentriq 2L bladder IMVigor 211 May 2017
Merck & Co Keytruda 2L head & neck Keynote-040 July 2017
Merck & Co Keytruda 2L gastric Keynote-061 Dec 2017
Bristol-Myers Squibb Opdivo 2L small cell lung Checkmate-331 Oct 2018

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