Tuesday, March 29, 2016 7:18:25 PM
>> There were no effective drugs other than chemo approved when Opdivo was tested.
Really? There were quite a few effective ALK/EGFR inhibitors out there, they are even more effective than PD1/PDL1 for those with ALK/EGFR mutations. One of several reasons Asians with NSCLC generally have higher mOS is because of much higher percentage of patients with EGFR mutation than the west, they could be treated with EGFRi in addition to chemo, even retreatment with EGFRi after chemo is relatively effective.
>> if there was other trials going on (pd-1, etc) it could be likely they would exclude patients from bavi trial and not those for chemo only drugs (blood tests).
Blood test of what? You are quite good at convincing yourselves on anything without knowing the process. Clinical trials typically exclude patients just out of other clinical trials for a certain period of time. Bavituximab has relatively short half life among oncology biologic which is why it is administered once a week. It would be out of patients' system completely by the typical time limit of clinical trial entry even if it were tested, btw they don't test that type of things before entry to clinical trials.
>> Bavi + chemo+ Opdivo = chemo + Opdivo.
How could you draw equation like that without seeing any data? There should be relatively few patients from SUNRISE onto Opdivo/Keytruda as subsequent therapy before futility halt because Opdivo/Keytruda were approved in non-squamous NSCLC only Oct 2015 in US. You are fixated on Opdivo as subsequent therapy right now while not paying attention when on Feb 20, 2016 before SUNRISE futility I first used Opdivo/Keytruda subsequent therapies as ONE of MANY factors several people didn't take into consideration in their projection of lopsided event ratio. Now you are making the same mistake. Clinical trials are complicated, rarely only ONE item affects outcome. Futility at only 33% events tell you everything you need to know or wait until data are presented if they ever, otherwise, some people are going to continue arguing why control arm in bavituximab 1st line NSCLC "outperformed" so called historical control for the rest of their life as if historical control should have stayed the same for the past 20 years no matter what and where patients were enrolled. For the record, the longest published mOS in 2nd line NSCLC trial with docetaxel I saw was 22 months.
>> So are we saying Bavi plus chemo was not helped further by Opdivo. That is probably because bavi + chemo alone is maxed benefit.
Really? Or bavituximab is simply not effective in combination with chemo for NSCLC. It is hard for many to accept, but based on totality of 3 ph2/3 NSCLC trials in chemo combination, it couldn't be any more clear to me. The company suspended all chemo combination trials further confirmed this. As of the only so called "successful" ph2, it was mainly due to imbalances among the arms created by no stratification during randomization - see similar CLDX ph2 - and the "high" mOS from 3mg/kg due to extremely high (44%) percentage of Asians and high (20%) percentage lost to follow-up. Once data from clinical trials are presented, it is much easier to pinpoint actual factors.
>> Question though is bavi + pd-1 better than Opdivo plus secondary after patients progress.
Don't bet on it unless there's some clinical data since NONE of the company's preclinical data have been validated in clinic so far. Plus it's always tougher to develop combination therapy than monotherapy especially one has little to no single agent activity.
Well, it's a wrap for me. Good luck!
Really? There were quite a few effective ALK/EGFR inhibitors out there, they are even more effective than PD1/PDL1 for those with ALK/EGFR mutations. One of several reasons Asians with NSCLC generally have higher mOS is because of much higher percentage of patients with EGFR mutation than the west, they could be treated with EGFRi in addition to chemo, even retreatment with EGFRi after chemo is relatively effective.
>> if there was other trials going on (pd-1, etc) it could be likely they would exclude patients from bavi trial and not those for chemo only drugs (blood tests).
Blood test of what? You are quite good at convincing yourselves on anything without knowing the process. Clinical trials typically exclude patients just out of other clinical trials for a certain period of time. Bavituximab has relatively short half life among oncology biologic which is why it is administered once a week. It would be out of patients' system completely by the typical time limit of clinical trial entry even if it were tested, btw they don't test that type of things before entry to clinical trials.
>> Bavi + chemo+ Opdivo = chemo + Opdivo.
How could you draw equation like that without seeing any data? There should be relatively few patients from SUNRISE onto Opdivo/Keytruda as subsequent therapy before futility halt because Opdivo/Keytruda were approved in non-squamous NSCLC only Oct 2015 in US. You are fixated on Opdivo as subsequent therapy right now while not paying attention when on Feb 20, 2016 before SUNRISE futility I first used Opdivo/Keytruda subsequent therapies as ONE of MANY factors several people didn't take into consideration in their projection of lopsided event ratio. Now you are making the same mistake. Clinical trials are complicated, rarely only ONE item affects outcome. Futility at only 33% events tell you everything you need to know or wait until data are presented if they ever, otherwise, some people are going to continue arguing why control arm in bavituximab 1st line NSCLC "outperformed" so called historical control for the rest of their life as if historical control should have stayed the same for the past 20 years no matter what and where patients were enrolled. For the record, the longest published mOS in 2nd line NSCLC trial with docetaxel I saw was 22 months.
>> So are we saying Bavi plus chemo was not helped further by Opdivo. That is probably because bavi + chemo alone is maxed benefit.
Really? Or bavituximab is simply not effective in combination with chemo for NSCLC. It is hard for many to accept, but based on totality of 3 ph2/3 NSCLC trials in chemo combination, it couldn't be any more clear to me. The company suspended all chemo combination trials further confirmed this. As of the only so called "successful" ph2, it was mainly due to imbalances among the arms created by no stratification during randomization - see similar CLDX ph2 - and the "high" mOS from 3mg/kg due to extremely high (44%) percentage of Asians and high (20%) percentage lost to follow-up. Once data from clinical trials are presented, it is much easier to pinpoint actual factors.
>> Question though is bavi + pd-1 better than Opdivo plus secondary after patients progress.
Don't bet on it unless there's some clinical data since NONE of the company's preclinical data have been validated in clinic so far. Plus it's always tougher to develop combination therapy than monotherapy especially one has little to no single agent activity.
Well, it's a wrap for me. Good luck!
