Bei tnbc, welcher am 10.12 in San antonio präsentiert wird ist nun öffentlich zugänglich:
PS3-08: Interim Overall Survival of Patients with Locally Advanced or
Metastatic Triple-Negative Breast Cancer treated with First Line
PM8002/BNT327 in Combination with Nab-Paclitaxel in Phase Ib/II Study
Presenting Author(s): Jiong Wu
Abstract Number: SESS-3600
Background: PD-L1 and VEGF play important roles in immune evasion and tumoral
angiogenesis, promoting cancer growth and metastasis. PM8002/BNT327 is an
investigational bispecific antibody targeting PD-L1 and VEGF-A, in development for the
treatment of solid tumors. We conducted a Phase Ib/II study of PM8002/BNT327 in
combination with nab-paclitaxel in pts with locally advanced or metastatic triple-negative
breast cancer (LA/mTNBC) in China. We provide updated results including interim overall
survival (OS) since initial reports at SABCS 2023 and ESMO 2024.
Methods: 42 Pts with previously untreated LA/mTNBC were enrolled till 11 Apr 2023 to
assess the safety and efficacy of PM8002/BNT327 in combination with nab-paclitaxel. All
patients received PM8002 at 20 mg/kg (Q2W) and nab-paclitaxel at 100 mg/m2 on the 1st,
8th, and 15th day of each 28-day cycle until unacceptable toxicity or disease progression
were observed. Efficacy was assessed every 8 weeks. Primary objectives were safety per
CTCAE 5.0 and objective response rate (ORR) per RECIST v1.1 by investigator assessment,
with progression free survival (PFS) and overall survival (OS) as secondary objectives.
Results: As of 13th Sep 2024, with a median follow-up time of 18.1 months (95% CI 16.9,
19.7), median duration of treatment was 10.0 months (range 2.0-22.0) with 9/42 patients
still on treatment. The confirmed ORR (cORR) was 73.8% with a disease control rate (DCR)
of 95.2%. The median time to response (TTR) was 1.9 months (95% CI 1.8, 2.0), the median
duration of response (DOR) was 11.7 months (95% CI 7.2, 17.3). The matured median PFS
was 13.5 months (95% CI 9.4, 18.1) for the ITT population. The median OS was not reached,
while the matured 12-month OS rate was 80.8% (95% CI 65,3, 89.9), the matured 15-month
OS rate was 78.1% (95% CI 62.1, 88.0) and the nearly matured 18-month OS rate was
72.2% (95% CI 55.2, 83.7). 38 pts had available PD-L1 expression results tested with E1L3N
assay. cORR was 76.9% in 13 pts with PD-L1 combined positive score (CPS) < 1 and 72.0%
in 25 pts with PD-L1 CPS ≥1. All 9 pts with PD-L1 CPS ≥10 achieved PR. All pts experienced
treatment-related adverse events (TRAEs), 59.5% were Grade 3 or 4, no Grade 5 TRAEs
were observed. The most common (≥30%) TRAEs included neutropenia, leukocytopenia,
anemia, proteinuria, alopecia, hypertriglyceridaemia, hypercholesterolaemia, epistaxis and
asthenia. 31.0% of pts experienced immune-related adverse events (irAEs), 9.5% were
Grade 3, no Grade 4 or 5 irAEs were observed. The most common irAEs included
hyperthyroidism, hypothyroidism and rash. The most common AEs typically associated
with VEGF inhibition were hypertension (23.8%) and proteinuria (64.3%) which were
mostly Grade 1 or 2.
Conclusions: In pts with LA/mTNBC, first-line therapy with PM8002/BNT327 combined
with nab-paclitaxel showed clinically meaningful survival outcomes and antitumor activity
regardless of PD-L1 status, together with a manageable safety profile. No new safety signals were observed beyond those typically described for anti-PD-1/PD-L1 and anti-VEGF
therapies and nab-paclitaxel. A randomized controlled Phase III clinical trial
(NCT06419621) of first-line treatment of TNBC in China and a global Phase II trial
(NCT06449222) are ongoing in TNBC
https://sabcs.org/Portals/0/Documents/...ahfFpG4FEZ_NWNqzxJiR5Q%3d%3d
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