NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

The mPFS of the 99 placebos was 7.6 months (5/10/22 NYAS presentation) and Lykiri counted a total of 81 progression events of whom 48 occurred prior to 7.6 months from randomization and 33 thereafter.

meirluc,

To be clear i didn't count the 81 PFS events. It's a fact that there are 81. You can find it here: https://investorshub.advfn.com/uimage/uploads/2022/5/11/jjgyh5-10-22-Slide-11.png

I counted 33 Confirmed PFS events beyond 7.6 months from randomization.
There are 48 Confirmed PFS events and maybe 3 or 4 ‘unconfirmed progression’ (uPD) events between 0 and 7.6 months from randomization, IMO.
Events initially classified as uPD which are not subsequently confirmed are censored.
You say:

For 99 patients a 7.6 months mPFS would imply that about 49-50 patients have progressed before 7.6 months and 49-50 would have progressed thereafter. I therefore should have concluded that most or all of the 18 patients that Lykiri did not detect as having progressed did progress after 7.6 months on trial.

NO.
5 placebo patients are censored between 0 and 12 months from randomization.
5 placebo patients are censored between 12 and 24 months from randomization.
8 placebo patients are censored beyond 24 months from randomization.
5+5+8 = 18 placebo patients
18 + 81 = 99 placebo patients

It’s a fact that 30 or 31 placebo patients are alive 36 months from surgery. ( 32.9 months from randomization)
20 MGMT methylated placebo patients, 5 or 6 MGMT unmethylated placebo patients and 5 MGMT Unknown placebo patients from the vanguard group (n=38).

I find it very interesting that only 3 MGMT methylated placebo patients died between 24 and 36 months from surgery. You see a very flat OS KM (MGMT methylated placebo patients) curve between 24 and 36 months from surgery. (between 20.9 months and 32.9 months from randomization)

Number of MGMT methylated placebo patients (n=41) at risk at 24 months from surgery = 23 MGMT methylated placebo patients (56%)
Number of MGMT methylated placebo patients (n=41) at risk at 36 months from surgery = 20 MGMT methylated placebo patients (49%)

Number of MGMT methylated DCVax-L patients (n=90) at risk at 24 months from surgery = 62 MGMT methylated DCVax-L patients (69%)
Number of MGMT methylated DCVax-L patients (n=90) at risk at 36 months from surgery = 40 MGMT methylated DCVax-L patients (44.5 %)

From the protocol:

3.1.3 Confirmed progression-free survival

Confirmed PFS (cPFS) will be measured from the date of randomization to the date of confirmed progressive disease (cPD; see section 1.2.2, Appendix C) or death. An initial determination of progression will be made in the same manner as for PFS (see sections 1.2.2, 3.1.4 and Appendix C): these events will for this analysis be qualified as ‘unconfirmed progression’ (uPD) events. Subsequent review of these events will then determine whether they can be confirmed, or not, and only events that are subsequently determined to be confirmed progression will be counted as events for the cPFS endpoint. Events initially classified as uPD which are not subsequently confirmed will be censored.

3.1.4 Progression-free survival

PFS is defined as the time from randomization until objective demonstration of tumor progression or death, whichever occurs first [10]. If neither tumor progression nor death are known to have occurred by the date of database lock, the date the subject was last known to be alive and progression-free will be used to calculate PFS, which will be considered censored.

https://cdn.jamanetwork.com/ama/content_public/journal/oncology/939074/coi220066supp1_prod_1674054620.80505.pdf?Expires=1684230321&Signature=asw~8LYcCpFbaMU7O-vtdFVmikbnaNHp4wWoMSBsBGtV4NfEZZXnAP2p2Oy5JWnsCOmn~3BUgJD1K9aNBV-kD-Z-a6wd9KJNhcsChvU4XYC1uTf0aVrhV8bcxu9eGnKlaE96yFPoa4NOEJzVbkmZXoOTYrZOuxTBwZQZT~uOYdQLGDGOJ06myJeEfqYEgiVmyfFMe5GNaQRT~9M83oDpdiJcFlY3p8a0lCHR54~V3pTcDxyzI2HMudSSy3mjNP~qEYIl0TETeBAMcGFrJCVZ6E3D7AciILYWnfIAR7JlbXVxOFfoiJZpRf~p50sqKnsux~IhRWQHCRgrCrMowsPWDg__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA