Michael Liontos, Associate Professor of Therapeutics -Oncology at Dept of Clinical Therapeutics, National and Kapodistrian University of Athens, shared on LinkedIn:
“KEYLYNK-001: Ιntroduction rejected.
This Sunday I read the full KEYLYNK-001 manuscript, recently published in The Lancet Oncology. I wanted to go through the results in detail and look for populations of interest.
The introduction follows a familiar path: standard of care, the unmet need, then preclinical and early clinical data suggesting PARP inhibitor plus immunotherapy combinations are promising.
My first thought was how much effort and money go into hypotheses that turn out to be wrong.
That is how science moves forward, but only if we learn from failure and stop prioritising signals that were always likely to be incremental. It’s a hard conversation our community needs to have.
What followed was more troubling.
The introduction then describes KEYNOTE-B96, a positive trial of pembrolizumab in platinum-resistant recurrent disease, in detail, including four hazard ratios and p values.
B96 was designed and read out long after KEYLYNK-001 started. It played no role in shaping this trial and shouldn’t be included in the introduction.
Updating the evidence landscape at the time of writing is legitimate. But then it has to be the whole landscape.
IMagyn050, JAVELIN Ovarian 100, DUO-O, FIRST and ATHENA-COMBO are the first-line immunotherapy trials that ran before or alongside KEYLYNK-001.
None of them are mentioned in the introduction. None showed a clear incremental benefit from adding checkpoint inhibition in the frontline setting.
You might expect the Discussion to engage with them. It doesn’t, really:
One short paragraph, shorter than the space given to supportive data in the introduction.
Read the interpretation and conclusion, and you could come away believing immunotherapy may still have a place in frontline ovarian cancer.
This is selective citation. It deprives readers of the context they need to judge the trial, and it presents the field as more promising than the evidence supports.
Negative trials are data too.
If we don’t put them front and centre, we will keep designing the next trial on the same incomplete picture.”
You can also read: OCRF and News Corp Australia Launch “Over It” Campaign to Close the Ovarian Cancer Survival Gap
