It seems that we are going in the same direction o
Post# of 155452
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Posted On: 02/21/2020 10:04:20 AM
It seems that we are going in the same direction of what Merck did with Keytruda once the drug was known to be beneficial across several indications.
The basket trials are mainly carried out for tissue-agnostic drugs. As our Leronlimab mechanism of action is very general and beneficial across different cancers (tumors) I believe the same applies to us.
Interestingly enough there have been only three cases of tissue-agnostic approvals so far (that I know of): Merck’s Keytruda (pembrolizumab) in May 2017, Bayer’s Vitrakvi December 2018 and Roche’s Rozlytrek (entrectinib) August 19, so is not an easy achievement; if we get approval we will be part of a very exclusive club.
A very interesting paper on this topic :
https://trinitylifesciences.com/wp-content/up...rtners.pdf
The interesting point here is that the basket trial can be converted in a “registrational strategy”
(Registrational trials are those intended to provide evidence for a drug seeking approval by the FDA).
If the data deterministically supports the mechanism of action of Leronlimab for some of the indications that will be attempted, the approval for others will be much easier as the cross-confirmation will be taken into account by FDA in the same manner it was accepted for the Keytruda case. That is, if it works with one tumor (for example BC), and seems to be working with another, in another cancer type, chances are that he MOA is confirmed therefore approval for the second will be granted more expeditiously.
Let’s hope that the new deluge of data that will start in two months is a confirmatory one. This will be like a rolling snow ball.
Only that green
if you catch my drift ...
The basket trials are mainly carried out for tissue-agnostic drugs. As our Leronlimab mechanism of action is very general and beneficial across different cancers (tumors) I believe the same applies to us.
Interestingly enough there have been only three cases of tissue-agnostic approvals so far (that I know of): Merck’s Keytruda (pembrolizumab) in May 2017, Bayer’s Vitrakvi December 2018 and Roche’s Rozlytrek (entrectinib) August 19, so is not an easy achievement; if we get approval we will be part of a very exclusive club.
A very interesting paper on this topic :
https://trinitylifesciences.com/wp-content/up...rtners.pdf
Quote:
“Historically, basket trials have been used to explore multiple tumor types in one trial in order to prioritize the ones with the greatest response for further research. However, last year Keytruda became the first therapy to successfully use basket studies as a registrational strategy. In May 2017, Keytruda was granted accelerated approval of a second line treatment for adult and pediatric patients with microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) solid tumors irrespective of histology.
With Keytruda’s MSI-H and dMMR approval, basket trials have now become a viable registrational strategy to pursue a tissue-agnostic indication. What does this mean for oncology treatment and for industry? Will this lead to a shift in the basic oncology treatment paradigm, as other therapies follow Keytruda’s lead and pursue tissue-agnostic indications? Or will this remain a relatively uncommon approach to clinical study and regulatory approval? The prospect of additional tissue-agnostic indications raises a number of interesting questions for multiple stakeholders involved in oncology care.”
The interesting point here is that the basket trial can be converted in a “registrational strategy”
(Registrational trials are those intended to provide evidence for a drug seeking approval by the FDA).
If the data deterministically supports the mechanism of action of Leronlimab for some of the indications that will be attempted, the approval for others will be much easier as the cross-confirmation will be taken into account by FDA in the same manner it was accepted for the Keytruda case. That is, if it works with one tumor (for example BC), and seems to be working with another, in another cancer type, chances are that he MOA is confirmed therefore approval for the second will be granted more expeditiously.
Let’s hope that the new deluge of data that will start in two months is a confirmatory one. This will be like a rolling snow ball.
Only that green
if you catch my drift ... 
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