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https://www.evaluate.com/vantage/articles/events/conferences...


Obviously these figures should be treated with the usual caution reserved for cross-trial analyses, and Nektar itself conceded that Pivot-02 was a single-arm trial; another factor making it difficult to interpret is the small number of patients involved.

The final judgement on bempegaldesleukin will not be possible until Nektar reports data from the pivotal programme, which comprises eight registrational studies in melanoma and renal, bladder and lung cancers, seeking to enroll over 3,500 patients in total. A phase III trial in melanoma is already recruiting, with primary completion set for 2023, according to clinicaltrials.gov.


Product......... F/U (yrs).ORR ........ CRR
Keytruda........ 5 ........52% ........ 25%
Opdivo ......... 4 ........45% ........ 18%
Opdivo + Yervoy. 4 ........58% ........ 21%
214 + Opdivo ... 1 ........53% ........ 34%



bold added by me. Let's unpack this a bit.

#1 Single arm trials are terrible trials unless you have no other choice (ie, ultra-rare diseases)
#2 Still another 4 years to change that CRR/ORR. Dont give me that "responses deepen with time" garbage. I dont buy it unless its reproduced in multiple large trials.
#3 Add at least 30%-50% to these timelines. If they are saying 3-4 years out, add at least a year. Assume this is dead money until then. You can save yourself alot of hassle (and likely dilution), if you do the david gardner approach and buy it on the way up once data reveals itself. Trust me, if that 3500 patient trial is positive, and the 10% ADR rate (vs 40% with opdivo/yervoy) stays the same, and if "responses deepen with time" - then there will be plenty of room to run. Sure it might rise 25% or more on that news, but that might be a 25% rise from half of today's levels. And that is assuming no one puts up better data than this in the meantime.

NKTR does not deserve a 6b valuation right now, and I suspect it will continue to lose ground, but the recent run up is still fresh in folks minds and some cling to the past and price anchor. that will wane between now and 2023.


-Fuma, NKTR bear since ~70% ago ;)
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