Roche Holding AG Virtual Oncology/SABCS Investor Event Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Emmanuel Papadakis - Deutsche Bank AG - Analyst : Hopefully me okay. Maybe I'll take 2, if I may. Congratulations on the data. Perhaps a question around subgroups and a question on potential labeling and guideline implications. So the question on subgroups is just we didn't get any disclosure of benefit by nodal subgroups, which is something we've seen in prior studies in a setting such as NATLEarE. So could you just confirm that the benefit in terms of hazard ratio was consistent in the node negatives, which was around 1/5 of the population in the study with those with a nodal count of 1 or 2 to 3? That would be very helpful. And then just in terms of labeling and guideline implications, perhaps you could give us a sense, it was a relatively high-risk population enrolled in the study to give us a sense of what you're anticipating the FDA label may look like? Are you anticipating a high-risk wording in Stage II and III patients or something akin to the Kisqali wording for adjuvant breast cancer or something close to Verzenio, which is indicated for node-positive, high-risk patients, for example? And then any thoughts you could share on NCN guideline implications as well would be helpful.

Question: Emmanuel Papadakis - Deutsche Bank AG - Analyst : Yes, that's very helpful. And I'll circle back in the queue if this in.

Question: Emmanuel Papadakis - Deutsche Bank AG - Analyst : I'll try and be quick. It was just a follow-up perhaps for Dr. Bardia on your optimism on potential use as a monotherapy in the lower-risk population. Just trying to understand that a little better since you had 0 patients classified technically as low risk in the study. As you mentioned, it was less than 15% Stage 1. In those, you had a 0.89 hazard ratio on IDFS. So just wanted to understand your optimism around potential clinical adoption in the lower to intermediate risk setting. Is that because you're expecting the regulatory agency may ultimately endorse a label explicitly encompassing a Stage 1 population? Is it because you're thinking oncology guidelines would recommend use in those patients? Or is it just that you think physicians will be so keen to upgrade their endocrine therapy for patients, they'll do that regardless of either of those 2 things? And then maybe just a follow-on on pricing. We have had some benchmarks established within the SERD space by the recent approval in LO and of course, EU. There's been times in the past where Roche has been very willing to come in later and take a more galitarian approach to pricing to open up access for a broader population. Is that something you would consider in this circumstance? It would seem presumably likely to access a broader population in the adjuvant setting, you might need to consider that.