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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | trastuzumab botidotin (A166) (HER2-targeted antibody-drug conjugate, Tubulin inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Excerpt:
...Evaluable or measurable HER2 positive (by ISH or NGS) disease or HER2 expressing disease....
Trial ID:
Source:
Title:
A Study of A166 in Patients With Advanced Solid Malignant Tumors
Excerpt:
...Determined HER2-positive disease (detected by ISH or NGS) or HER2-expressing disease by evaluation or detection....
Trial ID:
Less C2 evidence
Source:
Title:
Phase I study of A166, an antibody‒drug conjugate in advanced HER2-expressing solid tumours
Published date:
04/18/2023
Excerpt:
For all assessable HER2-positive breast cancer patients enroled in the 4.8 mg/kg and 6.0 mg/kg cohorts, the corresponding ORRs were 73.9% (17/23) and 68.6% (24/35), respectively, and the median PFS was 12.3 and 9.4 months, respectively. A166 has a recommended phase II dose of 4.8 mg/kg Q3W, manageable toxicity, good stability in the circulation and promising antitumour activities in HER2-positive breast cancer patients.
DOI:
https://doi.org/10.1038/s41523-023-00522-5
Source:
Title:
Updated results and biomarker analyses from the phase I trial of A166 in patients with HER2-expressing locally advanced or metastatic solid tumors
Published date:
05/26/2022
Excerpt:
All patients were evaluable for efficacy with the best ORR being 73.91% (17/23; 95% CI, 51.59 to 89.77) and 68.57% (24/35; 95% CI, 50.71 to 83.15), mPFS being 12.30 months (95% CI, 6.00 to not reached) and 9.40 months (95% CI, 4.00 to 10.40) in 4.8 and 6.0 mg/kg cohort, respectively. Of 23 pts treated at 4.8 mg/kg dose level, one had a confirmed and sustained complete response lasting 7+ months. The previously demonstrated preliminary clinical benefit of A166-ADC was maintained with no new safety signals, which demonstrated manageable toxicity and encouraging anti-tumor activity in heavily pretreated HER2-positive metastatic breast cancer patients.
DOI:
10.1200/JCO.2022.40.16_suppl.1037
Source:
Title:
A first in-human study of A166 in patients with locally advanced/metastatic solid tumors which are HER2-positive or HER2-amplified who did not respond or stopped responding to approved therapies.
Published date:
05/13/2020
Excerpt:
A166 demonstrated clinically meaningful efficacy in heavily pretreated patients with relapsed or refractory advanced solid cancers. The achievement of an ORR of 36% at efficacious dose levels and up to 100% in HER2 positive patients regardless of histology (2 CRC, 1 BC and 1 NSCLC) at the highest studied dose level exceed.
DOI:
10.1200/JCO.2020.38.15_suppl.1049
Trial ID:
