Avid Bioservices Inc (CDMO)

[nuke661]

Dew,

You have not come anywhere close to supporting your assertions. I've given up after checking out the first 6 links. You are 0 for 6 in your assertion that these drugs are better than Bavi. I'm sure you will come back with further excuses limiting the application for the drugs to make your case but as I am providing below everyone can search the links and see your assertion is false.

Response to 1st and 2nd trial links (same drug):
BMS-936558
http://seekingalpha.com/article/296295-bristol-myers-squibb-zeroes-in-on-a-blockbuster-cancer-drug
9-27-11
“With respect to efficacy, BMS-936558 has not been evaluated in large, randomized trials, but it still generated impressive signs of efficacy in multiple indications. The extent of this effect appears superior to what Yervoy demonstrated in early stage trials. Data presented last year at ASCO included a 30% response rate in patients with late-stage melanoma or renal cancer, which is very unusual for a single agent. BMS-936558 also had an intriguing signal in lung cancer with a response rate of ~10% and disease stabilization in an additional 40% of patients. It is important to note that response rate is believed to under-represent activity of immunotherapies, as they tend to be more subtle, with durable, long-lasting effects even after discontinuation of treatment.”

Hey Dew, were you sitting on the bolded italicized info when you were slamming the top line data early last year for the PPHM 2nd line NSCLC. Can you say hypocrisy?

From: http://www.hematologyandoncology.net/index.php/supplements/highlights-in-nsclc-from-the-2012-chicago-multidisciplinary-symposium-in-thoracic-oncology/
Clinical Activity and Safety of Anti-PD-1 (BMS-936558, MDX-1106) in Patients (Pts) With Advanced Non-Small-Cell Lung Cancer (NSCLC)
The safety population of 120 new patients had a mean age of 65 years, and most were men (61%). Patients were divided between squamous cell histology (39%) and nonsquamous cell histology (60%). Most patients had good ECOG PS (0 for 34 patients, 1 for 83 patients, 2 for 2 patients, and not reported for 3 patients). The number of prior therapies was 1 for 18 patients, 2 for 31 patients, 3 for 27 patients, and 4 or more for 40 patients. Platinum-based therapies had been administered in 94% of patients, and 34% had received a prior tyrosine kinase inhibitor.
BMS-936558 was generally well tolerated. AEs occurred in 64% of NSCLC patients. The maximum tolerated dose was not found. At the doses of up to 10 mg/kg included in this study, no relationship was apparent between dose and AE frequency. In the NSCLC patients, the common drug-related AEs were fatigue (18%), decreased appetite (10%), anemia (8%), nausea (7%), pyrexia (6%), and diarrhea (6%). Such events were consistent with the immunogenic activity of BMS-936558. Grade 3–5 related AEs occurred in 8% of the NSCLC patients. In patients with NSCLC, fatigue was the most common grade 3/4 toxicity (2% of patients). Grade 1/2 pneumonitis occurred in 6 (2%) patients, including 4 (3%) NSCLC patients. Among the patients with pneumonitis, 3 drug-related deaths occurred (2 patients with NSCLC and 1 with colorectal cancer).
Among the 76 patients with NSCLC who were evaluable for clinical activity, the ORR was 18% (Table 2). There were 14 cases of PR, which occurred at doses of 1 (1 of 18 patients), 3 (6 of 19 patients), and 10 mg/kg (7 of 39 patients), resulting in response rates of 6%, 32%, and 18%, respectively. Two additional NSCLC patients who had received the antibody at a dose of 10 mg/kg were awaiting a confirmatory scan, and thus had unconfirmed PRs.
The anti-PD-1 antibody was active in both squamous and nonsquamous NSCLC histologies. Responses occurred in 6 of the 18 patients with squamous histology (33%) and in 7 of the 56 patients with nonsquamous histology (12.5%). All 14 of the responding patients began treatment more than 24 weeks before the analysis, and 8 of these patients had a response that lasted 24 weeks or longer. Further, 3 patients had a persistent decrease in overall tumor burden in the presence of new lesions, so they were not classified as responders.
BMS-936558 can be administered safely in heavily pretreated NSCLC patients in an outpatient setting. BMS-936558 is well tolerated. The clinical activity of BMS-936558 in patients with previously treated, advanced NSCLC is encouraging and warrants further development of this agent in patients with advanced NSCLC.


Summary: can’t find any published MOS data for this drug in a 2nd line NSCLC trial. Throwing the BS flag.

Response to 3rd trial link:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3429597/
Oncoimmunology. 2012 August 1; 1(5): 791–792.
TG4010:A therapeutic vaccine against MUC1 expressing tumors
“This open-label study recently published in The Lancet Oncology enrolled 148 patients with stage IV NSCLC, 74 received cisplatine and gemcitabine plus TG4010 and 74 received the same chemotherapy alone.”
“With 43.2% of patients progression free at 6 mo in the experimental arm this second Phase II in NSCLC met its statistical endpoint too. In the control arm 35.1% of patients remained free of progression at 6 mo. Interestingly the magnitude of the improvement was more important on response rate: 41.9% vs. 28.4%. Furthermore the outcome in terms of survival of responding patients in the experimental arm was better than in the control arm (23.3 vs. 12.5 mo). This observation is similar to the better duration of response observed in melanoma patients receiving dacarbazine plus ipilimumab as compared with dacarbazine alone.7 Regarding overall survival the median survival in both arms were similar, 10.7 mo vs. 10.3 mo however a late separation of the curves, classic with immunotherapy products showed a better long-term survival for the experimental arm. Conversely more patients died early in the experimental arm.”
See the following link for more info on MUC1 expression:
http://clincancerres.aacrjournals.org/content/6/5/1917.full

Summary: Not better than current Bavi data and limited to population of MUC1 expressing tumors. I’m throwing the BS flag on this one too.



Response to 4th trial link:

insert-text-here
Pharmgenomics Pers Med. 2012; 5: 113–123.
Published online 2012 September 25. doi: 10.2147/PGPM.S24258

PF00299804 is a pan HER inhibitor, targeting EGFR, HER2, and HER4. In preliminary studies, it has been shown to be effective in patients with EGFR mutations in the first-line setting.70 In a randomized Phase II study comparing it with erlotinib in patients with NSCLC following progression on chemotherapy, an overall PFS advantage was achieved.71,72 A phase I/II study of this agent in Asian patients who were refractory to chemotherapy and erlotinib or gefitinib, showed antitumor activity without significant toxicity.73 Further studies with this agent are pending.

EGFR Data from this link: insert-text-here
EGFR has been previously shown to be dysregulated in NSCLCs by protein over expression, gene amplification, or mutations [8]. In unselected NSCLCs, EGFR mutations are found in 10% of cases from North America, western Europe, but are reported in 30–50% of patients of East Asian descent and mostly (> 50%) associated with adenocarcinomas with bronchoalveolar features that arise among non-smokers [9–13].
HER 2 Data from this link: http://www.mycancergenome.org/content/disease/lung-cancer/her2
HER2 mutations are detected in approximately 2–4% of NSCLC (Buttitta et al. 2006; Shigematsu et al. 2005;

HER1 Data from this link (need to read if you want to assess it because the data is on a slide image; expressed in 43% of large cell non-squamous NSCLC):
http://www.mesothel.com/asbestos-cancer/related-disease/non-small-cell-lung%20cancer/nsclc_HER1_EGFR.htm

Summary: Throwing the BS flag - again. Dew has been penalized on every play so far.




Response to 5th trial link:

http://www.ncbi.nlm.nih.gov/pubmed/22753918
Randomized phase II study of dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor inhibitor, versus erlotinib in patients with advanced non-small-cell lung cancer.
PURPOSE:
This randomized, open-label trial compared dacomitinib (PF-00299804), an irreversible inhibitor of human epidermal growth factor receptors (EGFR)/HER1, HER2, and HER4, with erlotinib, a reversible EGFR inhibitor, in patients with advanced non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS:
Patients with NSCLC, Eastern Cooperative Oncology Group performance status 0 to 2, no prior HER-directed therapy, and one/two prior chemotherapy regimens received dacomitinib 45 mg or erlotinib 150 mg once daily.
RESULTS:
One hundred eighty-eight patients were randomly assigned. Treatment arms were balanced for most clinical and molecular characteristics. Median progression-free survival (PFS; primary end point) was 2.86 months for patients treated with dacomitinib and 1.91 months for patients treated with erlotinib (hazard ratio [HR] = 0.66; 95% CI, 0.47 to 0.91; two-sided P = .012); in patients with KRAS wild-type tumors, median PFS was 3.71 months for patients treated with dacomitinib and 1.91 months for patients treated with erlotinib (HR = 0.55; 95% CI, 0.35 to 0.85; two-sided P = .006); and in patients with KRAS wild-type/EGFR wild-type tumors, median PFS was 2.21 months for patients treated with dacomitinib and 1.84 months for patients treated with erlotinib (HR = 0.61; 95% CI, 0.37 to 0.99; two-sided P = .043). Median overall survival was 9.53 months for patients treated with dacomitinib and 7.44 months for patients treated with erlotinib (HR = 0.80; 95% CI, 0.56 to 1.13; two-sided P = .205). Adverse event-related discontinuations were uncommon in both arms. Common treatment-related adverse events were dermatologic and gastrointestinal, predominantly grade 1 to 2, and more frequent with dacomitinib.

Summary: Limited application and results not as good as Bavi. Throwing the BS flag - again. My arm is getting tired already. Dew must train with the Raiders.


Ponatinib for Squamous Cell Lung Cancer
For Squamous Cell Lung Cancer – need more be said?
http://lungcancer.about.com/od/glossary/g/squamouccell.htm
"Squamous cell lung cancer is a form of non-small cell lung cancer. Eighty percent of lung cancers are non-small cell lung cancers, and of these, about 30% are squamous cell."

Already approved for chronic myeloid leukemia but after reading the following link the safety profile doesn’t appear to be anywhere near that of Bavi and as stated it has a limited PROJECTED application in NSCLC. No PII trial data yet that I can find.

http://www.ariad.com/about_iclusig

Summary: BS flag thrown for the last time tonight. None of these are even close to bettering Bavi for breadth of application and magnitude of results. Dew apparently isn't playing by the rules; he’s posting bad info; again.