Sunday, June 06, 2010 1:57:46 AM
A phase III random assignment trial comparing percutaneous hepatic perfusion with melphalan (PHP-mel) to standard of care for patients with hepatic metastases from metastatic ocular or cutaneous melanoma.
Well, this presentation went very well, I thought. The data was even better than the intial press release from April. The hepatic PFS (primary endpoint) was 245 days in the PHP arm and 49 days in the BAC (best alternative care) arm. There was no survival benefit on an intent to treat basis BUT (and this point is currently rattling the cyber sphere) 55% of the 49 BAC patients crossed over to PHP after progressing. Since OS analysis is based on MEDIAN survival of the group, if over 50% of BAC patients end up eventually getting PHP AND benefit similarly from the delayed PHP, then the survival curves should superimpose, as they do. The only way in a crossover trial for the OS curves to NOT superimpose when over 50% crossover would be if the delay in getting PHP resulted in a lesser clinical effect (which clearly was not the case). There was an interesting survival curve they showed comparing the BAC patients divided into whether or not they received PHP at any point. The curves were WIDELY separated, but the analysis was not prespecified and carries no analytic weight statistically. Overall PFS also signficant although less so than hepatic PFS, which is logical. This was 189 days vs 46 days. The response rate data was: 34.1% PR, 52.3% SD. It was noted that NONE of the patients who actually received PHP progressed on initial assessment. There is no question in my mind that this is clinically effective and I was surprised when the discussant, seemingly from left field, pooh-poohed the results and said it was biased, ineffective and not worthy??? The format of the presentations prevented any questioning or commenting of the discussants.
Recent DCTH News
- Delcath Systems Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • PR Newswire (US) • 05/03/2024 09:15:00 PM
- Delcath Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) • PR Newswire (US) • 04/04/2024 12:35:00 PM
- Delcath Systems Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update • PR Newswire (US) • 03/26/2024 11:30:00 AM
- Delcath Systems Closes $7 Million Private Placement • PR Newswire (US) • 03/20/2024 12:15:00 PM
- Delcath Systems to Host Fourth Quarter and Full Year 2023 Results and Business Update Call • PR Newswire (US) • 03/19/2024 01:00:00 PM
- Delcath Systems Appoints Martha S. Rook as Chief Operating Officer • PR Newswire (US) • 03/18/2024 09:20:00 PM
- Delcath Systems Announces $7 Million Private Placement • PR Newswire (US) • 03/15/2024 12:20:00 PM
- Delcath Systems Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • PR Newswire (US) • 03/08/2024 10:00:00 PM
- Delcath Systems to Participate in Upcoming Investor Conferences • PR Newswire (US) • 03/08/2024 02:00:00 PM
- Delcath Systems Announces Healthcare Setting Locator for HEPZATO™ KIT (melphalan/Hepatic Delivery System) • PR Newswire (US) • 02/22/2024 10:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/20/2024 09:26:39 PM
- Delcath Systems Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • PR Newswire (US) • 02/16/2024 10:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/14/2024 09:46:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/14/2024 09:46:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/14/2024 09:44:54 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/14/2024 09:44:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/14/2024 09:43:08 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/14/2024 09:03:02 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 03:08:18 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/13/2024 10:00:11 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/13/2024 09:26:41 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/02/2024 02:37:54 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/31/2024 09:03:03 PM
- Delcath Systems Receives Permanent J-Code (J9248) for HEPZATO™ (melphalan/Hepatic Delivery System) Effective April 1, 2024 • PR Newswire (US) • 01/31/2024 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/26/2024 09:25:56 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM