乌鸦传媒

Multiple studies presented at the 2020 European Society for Medical Oncology (ESMO) virtual congress showed favorable results for potential new cervical cancer treatments, and they are all on a path for accelerated FDA approval in the coming year.

In this exclusive 乌鸦传媒 video, , of the University of Arizona College of Medicine, discusses the highlighted studies.

Following is a transcript of his remarks:

The real breakthrough in ESMO and in the development space, is cervical cancer. So we are likely to have three accelerated approval opportunities in 2021. Accelerated approval these days generally is five countries, in the U.S., Canada, Australia, Singapore, and Australia [sic]. And that would likely be balstilimab, which is Agenus' anti-PD-1 [antibody], which is good. And it will also likely be tumor-infiltrating lymphocytes, [with a study] presented at ASCO last year with a 44% response rate.

And then, thirdly, tisotumab vedotin, which is an antibody drug conjugate against tissue factor made by Genmab and co-developed by Seattle Genetics. So those are three single-agent, second-line metastatic opportunities that are likely to get accelerated approval probably in those five countries.

And, also in 2021, it's likely that Cervical Empower 1, which is also a second-line opportunity for cemiplimab, which is a randomized trial versus physician's choice of chemotherapy, will likely report -- and all indications are, but nobody knows -- but that should be positive because chemotherapy does so poorly in second-line metastatic cervical cancer. So that will be a global approval of a checkpoint inhibitor, cemiplimab, very exciting for the rest of the world.

We'll probably get our second one balstilimab, but the rest of the world will get cemiplimab.

And then also moving to earlier, first-line metastatic disease, it's likely that KEYNOTE-826 will report, which adds pembrolizumab to chemotherapy, generally platinum taxane with or without bevacizumab. So, you know, the current standard-of-care first-line metastatic disease, generally is triplet therapy, platinum taxane bevacizumab.

KEYNOTE-826 is a randomized phase III trial, making it a quadruplet now with pembrolizumab. That study again, I don't know whether it will be positive or not, but it's likely to report in 2021 and all indications are that it will be positive.

So it's possible that we could have five FDA approvals -- two globally, three accelerated, four in second-line, one in front-line metastatic disease in 2021. So that is really exciting for patients most importantly. And, that's what I'm most excited about.

In two of those papers -- balstilimab, which also has zalifrelimab, which is a CTLA-4 combination with it, was presented by David O'Malley from Ohio State. And the tisotumab vedotin, was presented by Robert Coleman of U.S. Oncology.

Those are two key data sets, which were interesting for people, and tisotumab vedotin incidentally had a response rate of 24% -- substantially better, if you can do cross trial comparisons versus 14% for pembrolizumab. So that's a great opportunity.

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