Bladder Cancer Update & Renal Cell Cancer Update, 2017 (Video Program)Results of the Phase II IMvigor 210 trial of atezolizumab for patients with platinum-pretreated or cisplatin-ineligible and inoperable locally advanced or metastatic UBC
3:58 minutes.
TRANSCRIPTION:
DR GALSKY: So atezolizumab has been explored in a large Phase II study. The Phase II study, called the IMvigor study, enrolled 2 cohorts of patients. One cohort of patients had received prior cisplatin-based chemotherapy and then had disease progression. And the other cohort of patients were patients who were chemotherapy naïve but considered cisplatin ineligible. The cohort that received treatment for the cisplatin-refractory setting or the cisplatin-resistant setting was the first data that was reported and published in The Lancet. And that study showed that there was a response rate to treatment in that setting of about 15%, certainly not an incredibly robust response rate. But, importantly, the responses in the majority of patients on this study were not unlike what I described with this patient, really quite durable responses. And so while the response proportion is somewhat low, (1), it’s really as good or better than anything we’ve had in the past in this situation. Two, the responses are really quite durable, which is really unlike anything we’ve seen in this setting. And (3), the treatment is, in general, quite well tolerated, which differs from standard chemotherapy. DR LOVE: Of course that’s a theme that we’ve heard across oncology. And one of the related issues is whether or not it can ever be stopped. And even in this man, I wonder if you’re thinking about that. DR GALSKY: Yes. So that’s a discussion that we have not uncommonly. And in this patient it’s been a little bit less of a dilemma, although still somewhat of a dilemma, but a little bit less because he still has measurable disease even though he’s had this really prolonged response. I do have other patients who’ve had complete responses, who are out about 2 years, for whom this is really more of a major issue in terms of what do we do now. And patients, not surprisingly, are hesitant to stop treatment, as am I, to be honest. DR LOVE: So before we get into the other data, I’m just kind of curious. You mentioned that the trial allowed people without prior chemotherapy, if they were chemotherapy or, I guess, cisplatin ineligible. Right now, will the indication cover first-line therapy in a patient who has, for example, poor renal function and can’t get, say, cisplatin? DR GALSKY: So the initial indication for atezolizumab is for patients who’ve had prior cisplatin-based therapy — or, I should say, prior platinum-based chemotherapy and have had disease progression. The data in the first-line setting for cisplatin-ineligible patients, as I mentioned, was reported later. That study took a little bit longer to mature. In that cohort in the first-line setting, the response rate is more in the 24% range. That response rate is lower than what we see with standard chemotherapy with something like gemcitabine and carboplatin, but again, the responses are quite durable. And when you look at the survival of those patients compared to historical controls, it does appear that the needle might be being moved with this treatment. And so it’s certainly compelling data. There’s certainly an interest in the community to see this data lead to the ability to change practice. I have used this treatment for patients who are cisplatin ineligible for whom I think that chemotherapy would offer undue risk or, frankly, in patients who’ve refused chemotherapy. DR LOVE: So you’ve been able to get it paid for? DR GALSKY: Yep. Yes. DR LOVE: Interesting. DR GALSKY: Yep. DR LOVE: Interesting. I mean, you also have the concept of a less-toxic therapy. I mean, it kind of reminds me a little bit of, like, say, renal cell and melanoma with the idea of even if you have a therapy that might have a higher response rate, if they’re asymptomatic and they could wait, take a shot at launching them into a long-term remission. Do you think that’s the way it’s going to play out as time moves on? DR GALSKY: I think that’s a strategy that probably will be embraced. And that’s a strategy that patients who are, quote-unquote, refusing chemotherapy, I think that’s really in the back of many of their minds. They want to give this a shot and, if it doesn’t work, then maybe they will consider taking something that might be more burdensome to their quality of life. |