Avid Bioservices Inc (CDMO)

[cjgaddy]

SStar, re: Bavi Ph.2 CCR’s vs. ‘100% Reductions’…

In the Ph.2 Bavi+Doce/MBC/RepGA trial, the 5-28-10 ASCO PR said, “ORR was 61% (28/46) with 11% (5/46) achieving a Clinical Complete Response (CCR).” And yet the corresponding ASCO poster #1042/Fig1 showed 19.5% (9/46) patients reached “100% Greatest Reduction in SLD (Sum-Longest-Diameters) from Baseline” (“100%’ers”). So, why were those other 4 “100%’ers” not reported publicly as CR’s? Well, as Mojo suggests, either they didn’t “Confirm” in their RECIST 4-wk followup scans, or maybe METS developed that disqualified them, or XXXXX?? or YYYYY??
http://tinyurl.com/2eoz96r

In the Ph.2 Bavi+CP/MBC/India, the 5-27-10 ASCO PR said, “ORR was 74% (34/46) with 9% (4/46) achieving a Clinical Complete Response (CCR).” And yet the corresponding ASCO poster #1062/Fig1 showed 21.7% (10/46) patients reached “100% Greatest Reduction in SLD from Baseline”. So, why were those other 6 “100%’ers” not reported publicly as CR’s? Again, either they didn’t “Confirm” in their RECIST 4-wk followup scans, or maybe METS developed that disqualified them, or XXXXX?? or YYYYY??
http://tinyurl.com/28af5ee

In the Ph.2 Bavi+CP/NSCLC/India, the 6-4-10 ASCO PR said, “ORR was 43% (21/40)”, but NO MENTION of ANY CR’s. And yet the corresponding ASCO poster #7589/Fig1 showed 4.1% (2/49) patients reached “100% Greatest Reduction in SLD from Baseline”. Oddly, ASCO Abstract #7589, written with only Stage1(n=21) data, said, “4.8% (1/21) achieved CCR”. And, recall, the 2-4-09 “Prelim. data on 1st 17 evaluables” PR said, “1 patient achieving a Complete Tumor Response according to RECIST criteria.” So, what happened with those 2 “100%’ers” from the ASCO Poster? Same possibilities as above apply…
http://tinyurl.com/2g5cqof

Regardless of why only 9 of the 21 “Fig1 100%’ers” (all 3 trials) were reported in the ASCO PR’s as “Complete-Responses”, the facts are that that 19/92 (20.6%) of ADV.BREAST patients and 2/49 (4.1%) of ADV.NSCLC patients reached “100% Reductions” in their tumor size during those 3 Bavi Ph.2 trials presented at ASCO 2010.

= = = = = = = = = = = = = = 2010 ASCO POSTERS:
All 4 (3 Bavi’s, 1 Cotara) as PDF’s here:
http://www.peregrineinc.com/index.php?option=com_content&task=view&id=29&Itemid=45


Re: Figure1: Note there are 46 BARS shown – that’s one for EVERY patient in the trial (Stage1=15, S2=31). They took each of those Patient’s “BEST RESPONSE”, sorted them Best-to-Worse, and showed them in the Fig1 graph. Now, these Resp%’s are “BEST” (MAX) observed (I would assume RECIST ‘Confirmed’ too) for each patient, regardless of When in the 6x4wk dosing cycles they occurred. Also, for each Tumor Resp. on Fig1, it’s obvious that the patients regressed at some point – presumably the 9 100%’ers as well (??). Oh, the dotted line: that’s the 30% mark that starts the “Partial Response” category – note that there are 30 patients below (PPHM has publicly said only 28 Obj.Resp’s – obviously 2 were disqualified for some other reason) and to the left of it – that’s your 61% Overall Response Rate for the BREAST/GA. trial (“intent-to-treat” basis). One more, thing: there are DEFINITELY 9 100% Tumor Reductions (9/46=19.5%) showing on that graph!! (((PPHM’s ASCO’10 PR said 5 CR’s in this MBC/GA. trial, so maybe METS disqualified the 4 others from ‘CR’ status??))) Also, 14 of the 46 (30.4%) reached tumor reductions > 75%.
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Re: Figure1: Note there are 44 BARS shown – that’s one for EVERY Evaluable patient in the trial (2 were obviously Non-Evaluable). They took each of those Patient’s “BEST RESPONSE”, sorted them Best-to-Worse, and showed them in the Fig1 graph. Now, these Resp%’s are “BEST” (MAX) observed (I would assume RECIST ‘Confirmed’ too) for each patient, regardless of When in the 6x4wk dosing cycles they occurred. Also, for each Tumor Resp. on Fig1, it’s obvious that the patients regressed at some point – presumably the 10 100%’ers as well (??). Oh, the dotted line: that’s the 30% mark that starts the “Partial Response” category – note that there are 30 patients below (PPHM has publicly said only 28 Obj.Resp’s – obviously 2 were disqualified for some other reason) and to the left of it – that’s your 61% Overall Response Rate for the BREAST/GA. trial (“intent-to-treat” basis). One more, thing: there are DEFINITELY 10 100% Tumor Reductions (10/46=21.7%) showing on that graph!! (((PPHM’s ASCO’10 PR said 4 CR’s in this MBC/India trial, so maybe METS disqualified the 5 others from ‘CR’ status??))) Also, 18 of the 46 (39.1%) reached tumor reductions > 75%.
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Re: Figure1: Note there are 40 BARS shown – that’s one for EVERY “Evaluable” patient in the trial – recall, Stage1/n=21 had 4 non-evaluables, so Stage2/n=28 obviously had 5. They took each of those Patient’s “BEST RESPONSE”, sorted them Best-to-Worse, and showed them in the Fig1 graph. Now, these Resp%’s are “BEST” (MAX) observed (I would assume RECIST ‘Confirmed’ too) for each patient, regardless of When in the 6x3wk dosing cycles they occurred. Also, for each Tumor Resp. on Fig1, it’s obvious that the patients regressed at some point – presumably the 2 100%’ers as well (??). Oh, the dotted line: that’s the 30% mark that starts the “Partial Response” category – note that there are 21 patients below and to the left of it – that’s your 43% Overall Response Rate for the NSCLC trial (“intent-to-treat” basis). One more, thing: there are DEFINITELY 2 100% Tumor Reductions (2/49=4.1%) showing on that graph!! (((ASCO Abstract #7859 calls the 1st one in Stage1 a ‘Clinical Complete Response’))) Also, 11 of the 49 (22.4%) reached tumor reductions > 50%.