I did a deeper dive into the new formulation of Keytruda. While a subcutaneous shot, it is done in the doctor's office and takes about 49 minutes to administer while the infusion takes 117. So clearly it's not a quick shot like leronlimab or the GLP drugs. If you ask me it seems like an opportunistic attempt to preserve their patent protection for another cycle and keep the cash-cow pumping out the medical milk... At the expense of Medicare/Medicaid and all the patients that could benefit from a cheaper generic.
This new formulation is not approved yet; there is a PDUFA date scheduled for Sept 23rd later this year. It would be nice if the "new" FDA slapped down Merck on this... Otherwise, in the follow-the-leader pharmaceutical industry, this kind of strategy will become standard practice. But I'm not holding my breath!
I think it was Ritz who noted that Tecentric (atezolizumab/Roche) was the PD-1 inhibitor that three of the five long-term mTNBC survivors took with/after leronlimab. (Nice catch Ritz). And it turns out that Tecentric is also available as a subcutaneous shot, but in the doctor's office as with Keytuda. It was approved less than a year ago, September 12 2024. So the Roche connection is still in play for convenient delivery with leronlimab... if it comes to that.
In order to make these drugs subcutaneous they essentially add another drug to the mix to increase the body's ability to assimilate the drug. This is from the Roche press release announcing the approval of subcutaneous Tecentriq:
"The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream."
Sounds a little strange to me--degrading tissue to increase permeability--but a lot of medical science creeps me out.
Wanna take a guess at when Roche loses patent protection on intravaneous Tecentriq? 2028, same year as Keytruda. And as noted, they are already approved for subcutaneous. So there go my hopes that the FDA will put the kibosh on what I now realize is a pretty common strategy to evade patent expiration. I hadn't realized Big Pharma was so far along in this process... Oh well!
I hope--and suspect--Cytodyn is looking into all the different PD-1/PDL-1 inhibitors and looking at differences in efficacy and side effect profiles, as well as delivery options and the like. While I imagine one or two will rise to the top, so much is unknown at this point. For example, are there any head-to-head trials going on between these PD-1 inhibitors? Wouldn't that be helpful to know? And how do the LAG3 class of drugs (they are also considered checkpoint inhibitors) fit into the post-ESMO immune-oncology landscape? Inquiring minds want to know!
I'm sure Cytodyn has been working overtime on these issues since the news broke about the "Ladies" and the new MOA. Would be nice to hear something soon about what they've learned and who they may take to the dance... Or perhaps who takes them is the more appropriate way to phrase it.
From the ESMO connection--and the many great comments on the board--I'm thinking one of the European companies like GSK or Roche will partner up with us on oncology. But that's only a feeling... In fact, it's rank speculation!
This new formulation is not approved yet; there is a PDUFA date scheduled for Sept 23rd later this year. It would be nice if the "new" FDA slapped down Merck on this... Otherwise, in the follow-the-leader pharmaceutical industry, this kind of strategy will become standard practice. But I'm not holding my breath!
I think it was Ritz who noted that Tecentric (atezolizumab/Roche) was the PD-1 inhibitor that three of the five long-term mTNBC survivors took with/after leronlimab. (Nice catch Ritz). And it turns out that Tecentric is also available as a subcutaneous shot, but in the doctor's office as with Keytuda. It was approved less than a year ago, September 12 2024. So the Roche connection is still in play for convenient delivery with leronlimab... if it comes to that.
In order to make these drugs subcutaneous they essentially add another drug to the mix to increase the body's ability to assimilate the drug. This is from the Roche press release announcing the approval of subcutaneous Tecentriq:
"The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream."
Sounds a little strange to me--degrading tissue to increase permeability--but a lot of medical science creeps me out.
Wanna take a guess at when Roche loses patent protection on intravaneous Tecentriq? 2028, same year as Keytruda. And as noted, they are already approved for subcutaneous. So there go my hopes that the FDA will put the kibosh on what I now realize is a pretty common strategy to evade patent expiration. I hadn't realized Big Pharma was so far along in this process... Oh well!
I hope--and suspect--Cytodyn is looking into all the different PD-1/PDL-1 inhibitors and looking at differences in efficacy and side effect profiles, as well as delivery options and the like. While I imagine one or two will rise to the top, so much is unknown at this point. For example, are there any head-to-head trials going on between these PD-1 inhibitors? Wouldn't that be helpful to know? And how do the LAG3 class of drugs (they are also considered checkpoint inhibitors) fit into the post-ESMO immune-oncology landscape? Inquiring minds want to know!
I'm sure Cytodyn has been working overtime on these issues since the news broke about the "Ladies" and the new MOA. Would be nice to hear something soon about what they've learned and who they may take to the dance... Or perhaps who takes them is the more appropriate way to phrase it.
From the ESMO connection--and the many great comments on the board--I'm thinking one of the European companies like GSK or Roche will partner up with us on oncology. But that's only a feeling... In fact, it's rank speculation!
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