AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
In the context of overall survival, it must be noted that of the pivotal trials with agents approved for the treatment of RCC since 2005, six of seven failed to show a survival benefit (Table).
Drugs Approved for the Treatment of Renal Cell Carcinoma
Drug
Brand Name
Approved
Indication
Study Design
Clinical Endpoint(s)
Sorafenib
Nexavar
2005
Advanced RCC
sorafenib vs. placebo in 2nd-line patients
PFS for full approval; no OS benefit
Sunitinib
Sutent
2006
First-line metastatic RCC
IFN vs. sunitinib
PFS for full approval; no OS benefit
Temsirolimus
Torisel
2007
First-line metastatic RCC
IFN vs. IFN ± temsirolimus
OS benefit for temsirolimus vs. IFN; No OS benefit for low-dose temsirolimus + IFN
Bevacizumab
Avastin
2009
First-line metastatic RCC
IFN ± bevacizumab
PFS for full approval; no OS benefit
Pazopanib
Votrient
2009
First-line metastatic RCC
pazopanib vs. placebo
PFS benefit for full approval; no OS benefit
Everolimus
Afinitor
2009
Metastatic RCC following failure with sunitinib or sorafenib
everolimus vs. placebo
PFS for full approval
Axitinib
Inlyta
2012
Metastatic RCC following failure with one systemic therapy
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The efficacy advantage of tivozanib over sorafenib was consistent across subgroups in the study. In treatment-naïve patients advanced RCC (70% of total study population), tivozanib demonstrated a statistically-significant improvement in PFS with a median PFS of 12.7 months compared to a median PFS of 9.1 months for sorafenib (HR 0.756, 95% CI 0.580-0.985; P=0.037).
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Is this data inferior? >>> The Phase-III results for tivozanib in RCC were reported in January 2012. The trial, known as TIVO-1, evaluated the comparative efficacy and safety of tivozanib relative to sorafenib in 517 patients with RCC. TIVO-1 was the first registrational study in 1st-line RCC to compare an investigational agent against an approved VEGF therapy. Based on independent radiological reviews, tivozanib demonstrated a statistically-significant improvement in progression-free survival (PFS) with a median PFS (primary endpoint) of 11.9 months compared to a median PFS of 9.1 months for sorafenib in the intent-to-treat population (HR=0.797, 95% CI 0.639-0.993; P=0.042). Tivozanib's investigators reported a median PFS of 12.7 months which is the longest ever reported for a Phase III trial in treatment-naïve RCC. The objective response rate (ORR) for tivozanib was 33% compared to 23% for sorafenib (P=0.014).
I'm sorry, but what am I missing here that shorts begging to lose on this one are seeing?
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
I will promise you Doc, if you can actually show in the data how Tivo is inferior and "poorly active", I will write a short thesis on it. You have to back up your thesis why Tivo is "poorly active" using the data and defeat my long thesis with a thesis. For instance, If I say "Ariad's Pona is poorly active, I would def need to defend why that is and explain, and I would especially never short a position without a solid thesis. So I ask again, and anyone else, how EXACTLY is Tivo poorly active and inferior to Sona. If you cannot answer this with data, then you have a losing thesis. Also explain why the FDA would reject this drug based on the data as well. The OS has already been explained. You might be a doctor, but u are not understanding the data here, and many short, like with KERX for the same reason, are going to get severely burned on this one.
U sure u want to be married to a short position here?
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
Tivozanib was especially useful in treatment-naive patients, who comprised 70% of study population. In those patients, progression-free survival was 12.7 months with tivzanib and 9.1 months with Nexavar (HR, 0.756; P = .037). << inferior Doc?
The rate of dose interruptions due to adverse events was 18% for tivzanib compared to 35% for Nexavar (p<0.001). The rate of dose reductions was 14% for tivzanib compared to 44% for Nexavar (p<0.001). This is a strong sign of patient tolerability, which leads to better patient compliance.
so u would rather have a patient give up and die, why dont patients do well on those other drugs you mention? its called patient compliance, If patients cut their doses, or stop taking the drugs all together they wont do well on the drug now will they?
Are you really a practicing Doctor? an MD?
Further data shows that 74% of the patients who switched to tivzanib had evidence of tumor regression and overall confirmed response rate was 13% - a clear sign of strong efficacy. << inferior?
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
please explain where Tivo in the data is "poorly active" thanks! I hope you dont short stocks without knowing how to defend your short position -- that is how u lose a ton of money.
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patient tolerability "Dr." explain exactly where this drug is poorly active. So you disagree with other Doctors on the trial who say it has the best PFS they have ever seen?
if u short this drug thru Adcomm, u will lose, and u can mark this post.
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Tivozanib is being studied for triple negative breast cancer, its currently in P2, and company is geared towards a pivotal P3, alot of this will depend on approval of Tivo for RCC, that was my whole point in speaking of the 1.3B they can receive upon approval.
AV-203 is entirely different and not something at this current time to over spec on. follow?
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
The high short interest is mainly due to the public offering at $7.50. Those who bought the offering hedge for protection. Commonly, before a large catalyst event, those hedgers will "churn out" their shorts, so we see a down trend in short interest, until they get themselves in profit/even, then the stock runs from their last short cover.
One mistake in revenue projection by 2022 for AVEO, U are forgetting the other indications.
its BATON‐BC Phase II trial, which is designed to evaluate tivzanib in patients with triple‐negative breast cancer. Triple negative breast cancer is a lucrative market because there are currently no targeted therapies approved for this segment.
tivzanib's front line potential to treat such diseases as triple negative breast cancer and colorectal cancer is likely the reason Astellas is willing to pay AVEO over $1B in milestones.
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
Drugs Approved for the Treatment of Renal Cell Carcinoma
Drug
Brand Name
Approved
Indication
Study Design
Clinical Endpoint(s)
Sorafenib
Nexavar
2005
Advanced RCC
sorafenib vs. placebo in 2nd-line patients
PFS for full approval; no OS benefit
Sunitinib
Sutent
2006
First-line metastatic RCC
IFN vs. sunitinib
PFS for full approval; no OS benefit
Temsirolimus
Torisel
2007
First-line metastatic RCC
IFN vs. IFN ± temsirolimus
OS benefit for temsirolimus vs. IFN; No OS benefit for low-dose temsirolimus + IFN
Bevacizumab
Avastin
2009
First-line metastatic RCC
IFN ± bevacizumab
PFS for full approval; no OS benefit
Pazopanib
Votrient
2009
First-line metastatic RCC
pazopanib vs. placebo
PFS benefit for full approval; no OS benefit
Everolimus
Afinitor
2009
Metastatic RCC following failure with sunitinib or sorafenib
everolimus vs. placebo
PFS for full approval
Axitinib
Inlyta
2012
Metastatic RCC following failure with one systemic therapy
axitinib vs. sorafenib
PFS for full approval; no OS benefit
Tivozanib
First- & second- line metastatic RCC
tivozanib vs. sorafenib
PFS for full approval; no OS benefit
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
I'm sorry, but what am I missing here that shorts begging to lose on this one are seeing?
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
U sure u want to be married to a short position here?
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
The rate of dose interruptions due to adverse events was 18% for tivzanib compared to 35% for Nexavar (p<0.001). The rate of dose reductions was 14% for tivzanib compared to 44% for Nexavar (p<0.001). This is a strong sign of patient tolerability, which leads to better patient compliance.
so u would rather have a patient give up and die, why dont patients do well on those other drugs you mention? its called patient compliance, If patients cut their doses, or stop taking the drugs all together they wont do well on the drug now will they?
Are you really a practicing Doctor? an MD?
Further data shows that 74% of the patients who switched to tivzanib had evidence of tumor regression and overall confirmed response rate was 13% - a clear sign of strong efficacy. << inferior?
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
if u short this drug thru Adcomm, u will lose, and u can mark this post.
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
Do the DD on the BATON‐BC << that is where the big "hidden" value is.
Scott
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
AV-203 is entirely different and not something at this current time to over spec on. follow?
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
AVEO Poised To Move Higher Before FDA Adcomm Catalyst, Obamacare And Platform Potential [View article]
2 Oncology Biotechs For The Future [View article]
2 Oncology Biotechs For The Future [View article]
its BATON‐BC Phase II trial, which is designed to evaluate tivzanib in patients with triple‐negative breast cancer. Triple negative breast cancer is a lucrative market because there are currently no targeted therapies approved for this segment.
tivzanib's front line potential to treat such diseases as triple negative breast cancer and colorectal cancer is likely the reason Astellas is willing to pay AVEO over $1B in milestones.
Have you guys considered this?