Submitting pooled data from two failed studies and getting approval could be unprecedented in FDA history. At least, I could not find any example for that. Think about it. One study failed. Then another one. What Raj is trying to sell to FDA is post hoc analysis, looking at the data—after the experiment has concluded—for patterns that were not specified a priori. It is called data dredging. Many companies with failed phase 3 studies do post hoc analysis but to prove that drug works they must run another trial and get results before NDA submission. Why other failed companies do not follow the path that Spectrum is going to follow? I would not listen to what Raj says. He desperately wants Apaziquone approval. Most likely, his team met with FDA on Apaziquone many times but could not get a clear answer.
This study had two phases, dose-escalation phase with patients who developed solid tumors and maximum tolerated dose (MTD) phase with soft tissue sarcoma (STS) patients. They found objective responses (CR+PR) in 8% of patients in dose-escalation and in 12.5% of patients in MTD expansion. Disease control rate (CR+PR+SD) looks better, 72% in dose-escalation and 69% in MTD expansion.
"ORR can be used to get AA"
Yes, Folotyn, Belinostat and Marqibo were approved based on ORR. In all three cases, companies negotiated AA with FDA before starting trials. I am not sure that AA could be granted post-factum.
"I'm just looking for a buildup of evidence that indicates increasing vincristine per patient increases efficacy"
We need to wait for results from HALLMARQ and OPTIMAL studies. I think, reduction of peripheral neuropathy (safety) could be another approvable endpoint. See Chinese phase 3 study NCT02072785.
"Do you know the association?" No, this trial was started before the deal between Spectrum and CASI was announced. Interestingly, the trial sponsor, Luye Pharma, specializes in liposomal technology. After reading that, I realized that Vincristine Sulfate Liposome in their study is not Marqibo. CASI is going to compete with them in China. But I like the idea that incidence of peripheral neuropathy could be an end point of the study. Of course, if efficacy is not compromised.
All drugs and drug candidates against HER (1-4) target HER proteins, not genes. Antibodies against HER and TKIs, like poziotinib, have no effects on HER genes.
Gene targeting is a genetic technique that uses homologous recombination to change an endogenous gene. No drug can do that.
"Gene targeting has nothing to do with this discussion, at least based on the initial post"
Please, read the title of the original post.
Puma Biotechnology Expands Cohort in Phase II Trial of PB272 in HER2 Mutation Positive Cancer Patients. It is just one of 41 studies with PB272 (neratinib), the only drug candidate in Puma's pipeline. Puma has market cap $7.4B with no revenue. Unfair.
Acquiring Talon may or may not be a bad deal. If the results from German study (Optimal) are positive, the deal is definitely good.
To our Stockholders,
How should we vote?
Notice is hereby given that the 2015 Annual Meeting of Stockholders of Spectrum Pharmaceuticals, Inc. will be held at our corporate headquarters located at 11500 South Eastern Avenue, Suite 240, Henderson, Nevada 89052, on Monday, June 29, 2015 at 10:30 a.m. Pacific Time. The Annual Meeting will be held for the following purposes:
1. Election of Directors. To elect seven directors to serve until our Annual Meeting of Stockholders to be held in 2016, or until their successors are elected and duly qualified.
2. Approval of Flexible Settlement Feature for the Potential Conversion of Convertible Senior Notes. To approve the flexible settlement feature in connection with the potential conversion of our outstanding Convertible Senior Notes, which would allow us to settle the conversion of the Notes, at our option, with shares of our common stock and/or their equivalent cash value at the time of conversion.
3. Ratification of Selection of Independent Registered Public Accounting Firm. To ratify the selection of Deloitte & Touche LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2015.
4. Advisory Vote on the Compensation of Our Named Executive Officers. To approve, by a non-binding advisory vote, the compensation of our named executive officers, as disclosed in the Compensation Discussion and Analysis section of the Proxy Statement.
5. Other Business. To consider and act upon such other business as may properly come before the Annual Meeting or any postponements or adjournments thereof.
The MILO (MEK inhibitor in low-grade serous ovarian cancer)/ENGOT-ov11 study: A multinational, randomized, open-label phase 3 study of binimetinib (MEK162) versus physician’s choice chemotherapy in patients with recurrent or persistent low-grade serous carcinomas of the ovary, fallopian tube, or primary peritoneum.
Bradley J. Monk, MD
University of Arizona Cancer Center and Creighton University School of Medicine at Dignity Health St. Joseph's Hospital and Medical Center
A multicenter, randomized, open-label, phase 2 study of carfilzomib with or without ARRY-520 (filanesib) in patients with advanced multiple myeloma.
The AFFIRM Study: A multicenter phase 2 study of single-agent filanesib (ARRY-520) in patients with advanced multiple myeloma.
Preliminary results of TATTON, a multi-arm phase Ib trial of AZD9291 combined with MEDI4736, AZD6094 or selumetinib in EGFR-mutant lung cancer.
Geoffrey R. Oxnard, MD
Dana-Farber Cancer Institute
A phase I dose escalation study of the tolerability of the oral VEGFR and EGFR inhibitor vandetanib (V) in combination with the oral MEK inhibitor selumetinib (S) in solid tumors.
Wasiru Olugbenga Saka
Oxford University Hospitals NHS Trust
SWOG S1115: Randomized phase II trial of selumetinib (AZD6244; ARRY 142886) hydrogen sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in pretreated patients (Pts) with metastatic pancreatic cancer.
Vincent M. Chung, MD
City of Hope
A phase Ib study of selumetinib in patients (pts) with previously untreated metastatic Non-Small Cell Lung Cancer (NSCLC) receiving standard chemotherapy: NCIC Clinical Trials Group IND.215. NCT01783197.
Garth Andrew Nicholas, MD
Ottawa Hospital Regional Cancer Centre
3:27 PM - 3:39 PM
A phase Ib/II study of BRAF inhibitor (BRAFi) encorafenib (ENCO) plus MEK inhibitor (MEKi) binimetinib (BINI) in cutaneous melanoma patients naive to BRAFi treatment.
Ryan J. Sullivan, MD
Massachusetts General Hospital Cancer Center, Harvard Medical School
A phase Ib dose-escalation study of binimetinib (MEK162) in combination with weekly paclitaxel in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.
Rachel N. Grisham, MD
Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
5:12 PM - 5:24 PM
A phase Ib/II study of MEK162 (binimetinib [BINI]) in combination with imatinib in patients with advanced gastrointestinal stromal tumor (GIST).
Ping Chi, MD, PhD
Memorial Sloan Kettering Cancer Center