Tuesday, May 07, 2013 10:52:51 AM
There is no way to know if the disclosed PFS results will have any connection with the expected MOS results.
I am not even sure if it is possible to say that you could expect the first-line results to be better than the
second-line results. That would be true if you were talking about a trial comparing two chemotherapy regimens,
but we are not. Bavi is an immunotherapy and I can conceive of reasons for the second-line to be better than
first-line therapy, but to still expect very good first-line results. We know very little about the first-line trial.
We do not know anything about the patient characteristics. We do not even know what ECOG PS scores
are allowed. PS 0-2, or 0-1? The clinical trials webpage does not list this in the inclusion/exclusion criteria.
http://www.clinicaltrials.gov/ct2/show/NCT01160601?term=Bavituximab+OR+Peregrine&rank=4
Given all of this my expectations are for control MOS of 10 months and treatment MOS of 14-15 months.
I believe that Peregrine is waiting until approximately 80% of the treatment arm patients have died before announcing
the MOS results. This will eliminate second guessing about the effect censored patients would have on the ultimate result.
I also believe that the results will not be statistically significant because of the small trial size, but this is to be expected.
However, I do expect a good result for the hazard ratio. Remember that this is a phase IIb trial, not a phase III trial.
There is a big difference in expectations between the two.
Note that an increase of MOS of 40% would still be excellent and much better than the 19.4% seen in the Avastin + CP first-line NSCLC trial.
Here is an updated chart including 20 Phase III first-line NSCLC trials which had a control arm using carboplatin + paclitaxel (CP).
"By all means let's be open-minded, but not so open-minded that our brains drop out." - Richard Dawkins
Recent CDMO News
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 11:30:11 AM
- Avid Bioservices Announces Pricing of Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/07/2024 04:58:48 AM
- Avid Bioservices Announces Proposed Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/06/2024 09:32:07 PM
- Avid Bioservices Announces Certain Preliminary Financial Results for Third Quarter Ended January 31, 2024 • GlobeNewswire Inc. • 03/06/2024 09:31:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 09:30:18 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/26/2024 09:57:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/13/2024 12:34:35 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:39:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:38:30 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:37:38 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:36:27 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:35:47 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/11/2024 12:56:02 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/08/2024 09:32:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:56:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:55:07 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:53:58 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:51:57 AM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 12/19/2023 09:05:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:34:08 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:33:03 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:32:11 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:31:12 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:30:26 AM
HealthLynked Corp Announces Chris Hall as New Chief Technology Officer • HLYK • Mar 19, 2024 8:00 AM
Elevai Labs Launches E-commerce Portal to Support Rapid Growth as Stem Cell Exosome Disruptor in the $19.7 Billion Global Physician Dispensed Cosmeceutical Market • ELAB • Mar 18, 2024 8:51 AM
Prospera Energy Inc. Announces a 508% increase in the 2023 Proven Developed Producing (PDP) Reserve Valuation • PEI • Mar 18, 2024 8:09 AM
Greenlite Ventures Enters into Strategic Alliance with Woodway USA • GRNL • Mar 15, 2024 4:00 PM
HealthLynked Welcomes David Rosal as New Chief Financial Officer • HLYK • Mar 13, 2024 8:00 AM
ECGI Holdings, Inc. Announces Continued Efforts in Financial Optimization • ECGI • Mar 13, 2024 8:00 AM