Primary endpoint: overall response rate (ORR) at 6 months in AMPECT
(RECIST v1.1 criteria)

Overall Response Rate, Stabile Disease, Disease Control Rate Overall Response Rate, Stabile Disease, Disease Control Rate

*

Disease control rate was a post hoc exploratory endpoint and was not prespecified.1,2 Therefore it should be interpreted with caution.

DEMONSTRATED RESPONSE
39% ORR
at 6 months per independent review (12/31 [efficacy population], all PRs; 95% CI: 22%, 58%)

RAPID RESPONSE
1.4 months
median time to response (95% CI: 1.3, 2.8 months)1

DURABLE RESPONSE
Median DOR still not reached
2.5 years after the last patient initiated therapy; 50% of patients had a DOR of
36.1+ months (range 5.6,
55.5+ months)3

AMPECT=Advanced Malignant PEComa Trial; DOR=duration of response; PD=progressive disease; PEComa=perivascular epithelioid cell tumor; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumors; SD=stable disease.

In AMPECT, 2 patients experienced complete responses after 11 months and 34 months of treatment3

Target lesion changes at final analysis2,3

RECIST v1.1 criteria, per independent review

Overall Response Rate

*Target tumor reduction may not match Best Overall Response Assessment, which takes into consideration non-target lesions and the observations of new lesions as per RECIST v1.1.

One patient had an unconfirmed PR and thus best response is SD as per RECIST v1.1 (confirmation of response requirement).3

One patient with overall CR had a measurable lymph node as target tumor, but <10 mm.2

§One patient with a CR of target tumor reduction has a PR as best response because of unresolved nontarget lesions.1

Image was adapted from Wagner et al. Target lesion changes per mutational status – final analysis figure. CTOS; 2021.

AMPECT=Advanced Malignant PEComa Trial; CR=complete response; PD=progressive disease; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumors; SD=stable disease.

Durable response: median duration of response still not reached after 2.5 years3*

Secondary endpoints
(Kaplan-Meier estimates)

MEDIAN DURATION OF RESPONSE3
Not reached
(range 5.6, 55.5+ months)

Duration of Response Duration of Response

MEDIAN PFS3*

Progression-Free Survival Progression-Free Survival

MEDIAN OS3*

Overall Survival Overall Survival
Responses that last

Responses that last:

58% (7/12) of responders experienced a response lasting ≥24 months

Responses that last:

58% (7/12) of responders experienced a response lasting ≥24 months

*

Survival data should be interpreted with caution given the single-arm study design.

OS=overall survival; PFS=progression-free survival.

References: 1. Wagner AJ, Ravi V, Riedel RF, et al. nab-Sirolimus for patients with malignant perivascular epithelioid cell tumors. J Clin Oncol. 2021;39(33):3660-3670. doi:10.1200/JCO.21.01728 2. Data on file. Aadi Bioscience, Inc.; 2021.3. Wagner AJ, Ravi V, Riedel RF, et al. Final analysis from AMPECT, an open-label phase 2 registration trial of nab-SIROLIMUS for patients with advanced malignant perivascular epithelioid cell tumors (PEComa). Abstract presented at: CTOS Virtual Annual Meeting; November 12, 2021.