Replies to post #125619 on Biotech Values

[projectchris]

In non-PC patients (I.e where Bone mets much less common)? Of the almost exactly the same distributions and magnitude. I'd suggest that borders on the incredible. And if the same effect exists for anemia (which I missed) then that too begs questions IMO - although not as obviously incredible IMO.

Ovarian cohort
http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=82365

Results: Accrual was halted at 68 pts based on an observed high rate of clinical activity. The median number of prior systemic treatments was 2. Most common related AEs =Grade 3 were hand-foot syndrome (10%), diarrhea (8%) and fatigue (4%). Dose reductions and permanent discontinuations for AEs occurred in 43% and 10% of pts, respectively. Of 51 pts evaluable for mRECIST RR at 12 wks, 28 are R, 17 are S, and 6 have unknown status. mRECIST RR at 12 wks: overall = 12/51(24%), R = 5/28(18%); S= 5/17(29%). Five additional PRs await confirmation. The overall DCR (PR+SD) at wk 12 is 58% (30/51). After a median f/u of 4 mos (range: 1 to 11 mos), the median duration of response and median PFS have not been reached. CA125 responses (assessed by GCIG criteria) in 40 pts with =1 post-baseline result: 7/40 (18%). Median maximum increase in hemoglobin (Hb) in anemic pts (Hb < 11 g/dL) was 1.9 g/dL (N=8 in pts w/ = 6 wk f/u; range, 1.1-3.2 g/dL). All maximum Hb changes occurred w/in the first 12 wks.

RDT all available tumor types
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=80906


Results: 398/483 enrolled pts were evaluable for the lead-in stage. 154/398 (39%) had bone mets at baseline (68 with bone scan f/u). Median # prior regimens was 2. Most common related AEs grade = 3: fatigue (9%), hand-foot syndrome (8%), and HTN (5%). Dose reductions and permanent discontinuations for AEs occurred in 41% and 12% of pts, respectively. Soft tissue effects: ORR at wk 12: overall = 34/398 (9%); O 12/51 (24%), H 4/29 (14%), P 5/100 (5%), NS 6/60 (10%), B 2/20 (10%), S 1/21 (5%), M 4/76 (5%). 12 additional PRs await confirmation. 226/328 (69%) with =1 post-baseline scan had tumor regression. Highest DCR (PR + SD) at wk 12: H (76%), P (71%), and O (58%). Bone effects: 59/68 pts (P, B, and M) with bone mets and =1 post-baseline bone scan had partial or complete bone scan resolution, often with symptom improvement seen by wk 6. Osteoclast effects were observed across tumor types: 66/121 (55%) pts ± bone mets had declines of =50% in plasma C-telopeptide. Decreased serum tALP seen in P. Median max rise in hemoglobin in anemic pts (Hb < 11 g/dL) = 2.3 g/dL. All max Hb changes w/in first 12 wks. Randomization in cohorts P and O was halted and pts unblinded due to observed efficacy.

[biomaven0]

In non-PC patients (I.e where Bone mets much less common)? Of the almost exactly the same distributions and magnitude. I'd suggest that borders on the incredible.

I think you are missing the fact that it looks like they only tested CTx in patients with cancers where bone mets are reasonably common. Thus in the non-prostate cohort where they tested Ctx, over 60% (46/73) in fact had bone mets. So it's not too surprising that the effect was similar.

Peter