Timothée Olivier: PFS Censoring in DeLLphi-304 Trial
Timothée Olivier, Medical Oncologist and Attending Physician at the Oncology Division of Geneva University Hospital in Switzerland, shared on X:
“Update, thanks to Giannis Mountzios and to Amgen, I got this reply:
“Thank you for your comment. The authors confirm that all patients randomized in DeLLphi-304 have been accounted for in the efficacy analysis according to the statistical analysis plan. In particular, progression-free survival includes death as event, thus patients who drop out of treatment could still contribute to PFS as death events.”
However, looking at the PFS censoring rules from the protocol (screenshot below), if I follow the logic of Amgen’s explanation, this would mean that most of the 11 patients who never started the protocol control arm therapy must have died without ever receiving any new anti-cancer therapy.
That still strikes me as very surprising, and is still an important imbalance as compared to the tarlatamab arm. Perhaps it’s another subtle tweak we need to be aware of when it comes to censoring interpretation in PFS analyses!
I’ll try to discuss this directly with the sponsor and hopefully get back with more!”
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