SWOG

You can do target radiation and not whole brain radiation, and that's going to decrease the cognitive side effects of this.

So this is SWOG 1827 or the Maverick study.

304 patients with limited or extensive stage small cell randomized to either PCI or no PCI.

So prophylactic cranial radiation or not.

One question from the conference isn't about a drug.

Can MRI surveillance spare patients preventive brain radiation? SWOG's Phase III.

MAVRIC enrolled small cell lung cancer patients after initial treatment with no brain metastases.

Among 304 patients, MRI surveillance alone improved cognitive failure-free survival versus surveillance plus preventive radiation, hazard ratio zero point six zero.

We are now known in lung cancer to have cool lung cancer names for trials.

So first, I love MAVERICK, also known as the SWOG S1827, but I will stick with the MAVERICK.

Will you mind just walking us through the designs of the study? Who was eligible, and what were the two arms of the study?

Yes, absolutely.

So the SWOG S1827 MAVERICK trial was a randomized phase III trial of brain MRI surveillance plus or minus prophylactic cranial irradiation, or PCI, for patients with small cell lung cancer.

The trial enrolled patients with either limited or extensive stage small cell lung cancer after completing upfront therapy with no evidence of brain metastases on MRI within 28 days of enrollment.

Patients were randomized one-to-one to MRI surveillance with and without prophylactic cranial irradiation.

Um, yeah.

And I guess when to give checkpoint inhibitors leads to a broader question of the sort of slide that we see in malignancies where we start using therapies in the very advanced setting and then migrate to adjuvant and then neoadjuvant, for instance.

You know, one of my good friends in the field is Sapna Patel, who I think has thought a lot about this question through the context of her SWOG study.

Is neoadjuvant

therapy with checkpoint inhibitors now kind of a standard practice in melanoma? Where does this sit for most patients?

Neoadjuvant therapy is now very much a standard choice.

It's a preferred choice if someone has otherwise resectable gross metastatic disease, where in the past you might say, oh, let's just ask one of our surgical oncology colleagues to take this out and then we'll give someone adjuvant therapy.

I mean, Sopna's landmark 1801 SWOG trial really changed that paradigm completely.

A really elegant study, very, very expertly executed, which showed that neoadjuvant therapy is far superior to adjuvant therapy, in that case with single-agent anti-PD-1.

It also may eliminate microscopic disease, minimize toxicity and recurrence.

And there's also this biological consideration where because we are talking about immunogenicity and engendering an immune response in the body against the cancer, if there is more cancer in the neoadjuvant setting, because the cancer is still in situ, compared to when it's been resected, is that going to increase the effectiveness of the immunotherapy? And this was supported by a phase one Opacin, O-P-A-C-I-N trial, as well as neoadjuvant data involving pembrolizumab with SWOG-1801, which is a regimen that we use in my center You know, we've got a very prominent melanoma specialist and for patients who are perhaps a little bit more frail, using three cycles of neoadjuvant pembrolizumab followed by three cycles of adjuvant pembrolizumab is a very viable option.

I've seen plenty of patients get that regimen and have a complete pathological response.

But again, the overall survival data is still lacking and the sample size was small in that study.

And statement 20 takes us into the BCG naive space where we finally have randomized strain data.

Can you tell us about SWOG S1602?

Sure.

That was actually a really important trial because it starts to ask the question, does strain of BCG matter? And in a world in which we don't have enough manufacturers of BCG, this may become increasingly important.

And the second one we want to talk about in conjunction is Brian Chapin's phase two trial from the US, again, of cytoreductive radical prostatectomy versus best systemic therapy alone.

And I suppose that was the precursor to the big SWOG study, the big phase three trial that's ongoing.

So, yes, two interesting papers, plus an editorial going with it, Albie.

Tell us a bit about your thoughts on these.

Great summary, Albie.

And we remember Brian Chapin presented the study at EAU this year and of course, negative trial.

But like you said, a lot of takeaway points from that still, as we look forward to the big phase three SWOG trial.

And similar with the RAMP trial, you know, there's certainly a lot of interest in that trial.

Patients don't want it, and increasingly, neither do us doctors.

Uh, you commented on the important SWOG study looking at low tumor burden patients, uh, comparing Rituximab to Mocanituzumab.

AstraZeneca is taking a big swing, and we're taking it along with them, trying to move Cerivadimab on the basis of these very impressive relapse data and running our-- going right to the first line setting and comparing this as monotherapy to standard of care cytotoxic chemotherapy.

Um, we had the safety run and data reported out, and we actually just received word this week that the FDA has green-lit the global ran-- the American participation in the randomized phase three component.