Unfortunately, 10-Q page 35 says: In January 20
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Posted On: 01/11/2022 11:31:08 AM
Unfortunately, 10-Q page 35 says:
I'm not sure why it says "second-line treatment of mTNBC," unless I guess that is the indication for which we applied. I thought IMMU/GILD's Trodelvy/sacituzumab was more third line (or second line in certain circumstances of rapid progression?) for mTNBC, and I thought our Phase II trial combining leronlimab with carboplatin was for first-line treatment of mTNBC / naive in metastatic setting. In any event, it would be good to see updated #s from our mTNBC trials / compassionate use protocols, and hear an update on future development plans. I assume we will keep plugging along with our Phase II LL/carboplatin combo trial at 700 mg dosing, expanding in this Cohort another 36 (up to 48) subjects?
I do think the proper comparison group for this trial is first line vs. carboplatin alone (historical cohort), but I'm probably missing something. I see in prior posts I mistakenly wrote that this was a randomized trial, and it's not. There is no randomized placebo group.
Kevin
Quote:
In January 2022, the FDA notified the Company that its mTNBC data did not demonstrate a substantial improvement over existing mTNBC therapies; therefore, it could not grant Breakthrough Therapy designation. The FDA indicated that the Company may submit a new request with additional clinical evidence that demonstrates a substantial improvement in second-line treatment of mTNBC over existing therapies. The Company plans to submit a new request, with the additional data from the ongoing trial, when available.
I'm not sure why it says "second-line treatment of mTNBC," unless I guess that is the indication for which we applied. I thought IMMU/GILD's Trodelvy/sacituzumab was more third line (or second line in certain circumstances of rapid progression?) for mTNBC, and I thought our Phase II trial combining leronlimab with carboplatin was for first-line treatment of mTNBC / naive in metastatic setting. In any event, it would be good to see updated #s from our mTNBC trials / compassionate use protocols, and hear an update on future development plans. I assume we will keep plugging along with our Phase II LL/carboplatin combo trial at 700 mg dosing, expanding in this Cohort another 36 (up to 48) subjects?
I do think the proper comparison group for this trial is first line vs. carboplatin alone (historical cohort), but I'm probably missing something. I see in prior posts I mistakenly wrote that this was a randomized trial, and it's not. There is no randomized placebo group.
Kevin
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