It’s not a study that moves an already approved agent into an earlier line. It’s not a study that is testing a different radio labeled PSMA 4 agent. It is not a different chemotherapy agent in a different line. It is not a different androgen access-targeted agent. Cabo atezo is the first TKI IO combination to demonstrate positive results representing a unique treatment option for patients, and we believe that it is our imperative to bring it to these patients. Not only do we believe this, but many of the KOLs that we interacted with at GU ASCO believe this, and the patient advocacy groups that we interacted with believe this. Patients want alternative treatment options, and approval doesn’t mean that everyone is now going to be treated with the therapy.
However, if the therapy is not approved, no one, not even those who seem to benefit most from this combination, will be able to receive it.
Asthika Goonewardene: Thanks Amy that is really helpful. And I’ll follow up on my congratulations on this data and your restraint from not getting up and saying something to Dr. Chi at his podium comment. Maybe if I can squeeze one more in. Can we – there was a previous question on 002. Can you – I know it’s stay tuned for updates. Could you maybe give us a little color and tell us which of the cohorts have completed recruitment?
Amy Peterson: So I’m not able to give that to you at this point in time. Again, we have multiple cohorts. And just because they’ve completed treatment doesn’t necessarily mean that they are the first to read out. Remember, we have to follow for duration of therapy. We have to follow for progression-free survival, and we have to follow for OS. And even if the cohort is completed, it doesn’t mean that we will have data in the coming months.
Asthika Goonewardene: Got it. Okay. Well, I’ll stay tuned. Thank you so much for taking my question, guys.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Andy Hsieh with William Blair. Your line is open.
Andy Hsieh: Great. Thanks for taking our questions. And congratulations on achievements both in the clinical and financial fronts. Also, it’s really nice to see cabo’s profound activity in the virtual metastases subgroup and cabo again in the prostate cancer space. I want to ask specifically about the PFS delta. It was discussed during the discussion at ASCO to you, coinciding with the standing interval. I’m just curious, have you done or planning to conduct an analysis to roll that scenario out? And separately, regarding the Arcus collaboration, combining zanza with the HIP2, looking at previous cabo plus belzutifan combination, it appears that cabo is doing most of the heavy lifting on the efficacy front. So do you expect differentiation from this novel combination? Thank you.
Amy Peterson: Okay. So can I just get a clarification on the question with regard – I heard a couple in there. So cabo in the subgroups – sorry, cabo from – comment in the subgroups and the data that we showed at ASCO and subgroup. The PFS rule out scenarios, were you talking about the sensoring? What – can you repeat that question?
Andy Hsieh: Yes, yes, certainly. Yes, if you want to comment on the sensoring, yes, we have questions on that, too. But I guess my question was specifically talking about the PFS delta, right? So between the experimental arm and the control arm, really close to the scanning interval of nine weeks. And that was kind of brought up at the discussion. And I’m just curious about – if you can rule that out, basically. The delta of the PFS could potentially be an artifact of the scanning interval.
Amy Peterson: Okay. Now I understand your question much better. Thank you. So with regard to the PFS delta, one thing, take a step back, and we do look at many parameters of clinical benefit, not just an improvement in a single point in time. In general, the optimal way to view the treatment effect is really based on the hazard ratio, which looks at the difference between experimental and control arm across the entire PFS analysis, not at one point estimate, i.e., the median here that you’re referring to. There are multiple examples of no benefit at the median, but a positive hazard ratio resulting in approval going all the way back to ipilimumab in melanoma and really most recently, belzutifan in RCC, where the curves separate after the median, yet, clinical benefit was identified and the drugs have been approved.
Going into what we have observed in our study, we have very robust PFS findings seen across all subgroups, similar in the ITT population and according to the PCWG Working Group criteria. We believe that these are clinically meaningful PFS benefits, especially in this patient population in CONTACT, which represents overall a worse prognosis than other studies conducted in this space. We have a lot of – this – 100% of patients had measurable disease. 40% had visceral disease. In the ITT, our hazard ratio of 0.65 translates to a 50% improvement over the control arm, which is exactly what we saw at the median 4.2 versus 6.3 months. In the liver MET subgroup, the hazard ratio of 0.43 translates to a more than doubling the improvement over control arm.
And in fact, at the median, we observed a trebling of the effect from 2.1 to 6.2 months. In the patients with prior docetaxel, the hazard ratio was 0.57, which translates to a 75% improvement over the control arm. And in that median, we saw a doubling of median PFS from 4.1 to 8.8 months. So this is part of the totality of data, but it is not all of the totality of data. And in CONTACT-02, we have to also consider the patients that were enrolled and how they are unique and distinct from other studies that have evaluated drugs against second NHT. We have to consider the unmet need that is existent in this space and other important outcomes that we looked at. For example, I mentioned time to chemotherapy. We delayed time to chemotherapy with Cabo-Atezo.
