Friday, Immutep Limited (NASDAQ:IMMP) released results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase 2b trial of eftilagimod alfa (efti) in combination with Merck & Co Inc (NYSE:MRK) Keytruda (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression.
The updated efficacy and safety data was presented at the ESMO Virtual Plenary session.
The investigational immuno-oncology (IO) combination utilizing efti and Keytruda achieved an objective response rate (ORR) of 35.5% (11 of 31 evaluable patients) and a disease control rate (DCR) of 58.1%.
The company says the results are among the highest recorded for a chemotherapy-free approach in negative PD-L1 patients and compare favorably to a historical control of 5.4% ORR and 32.4% DCR from anti-PD-1 monotherapy.
Additionally, the IO combination attained a high complete response rate of 9.7% (3 of 31 patients). This compares favorably to a historical control of 0% from anti-PD-1 monotherapy in 1L HNSCC patients with a Combined Positive Score (CPS) <1.
One patient with early progressive disease evolved into a confirmed partial responder who remains on therapy after 14 months, resulting in a 38.7% ORR for the IO combination.
Response durability is tracking well, as has been seen in other clinical trials when efti is combined with Keytruda.
Over 50% of patients in Cohort B received treatment for at least six months, with three additional patients nearing this threshold at the data cutoff (11 March 2024). The combination also has a favorable safety profile, with no new safety signals observed.
In April, Immutep reported preliminary topline results from Cohort B of the TACTI-003 Phase 2b trial, demonstrating an ORR of 26.9% and DCR of 57.7% in 26 patients whose tumors do not express PD-L1, which compares favorably to historical controls.
Price Action: At last check on Friday, IMMP shares were up 19.4% at $2.39 during the premarket session.
週五，Immutep有限公司（納斯達克：IMMP）發佈了Cohort b的TACTI-003（KEYNOTE-PNC-34）第20億次試驗的結果，評估了與Merck＆Co Inc（紐交所：MRK）Keytruda（pembrolizumab）聯合治療無PD-L1表達的頭頸部鱗狀細胞癌復發或轉移患者的一線治療的eftilagimod alfa（efti）。
最新的療效和安全性數據在ESMO虛擬全會上發佈。
使用efti和Keytruda的IO聯合治療實現了35.5％（31名可評估患者中的11名）的客觀緩解率（ORR）和58.1％的疾病控制率（DCR）。
該公司表示，針對無PD-L1患者的無化療藥物療法的ORR爲5.4％，DCR爲32.4％，此次試驗結果是最高記錄之一，並比抗PD-1單藥療法的歷史對照更好。
此外，IO聯合治療在31名患者中實現了高達9.7％（3名患者）的完全緩解率。這與CPS＜1的1L HNSCC患者抗PD-1單藥治療的0％歷史對照相比更爲優異。
1例早期進展患者的病情已得到確認的部分緩解，該患者服用治療已達14個月，IO聯合治療的ORR爲38.7％。
響應持久性良好，這在與Keytruda聯合使用efti的其他臨床試驗中也表現出來。
Cohort b的50％以上的患者接受了至少六個月的治療，在數據截止日期（2024年3月11日）時另外三名患者接近這一閾值。聯合治療的安全概況也良好，沒有觀察到新的安全信號。
今年4月，Immutep報道了TACTI-003第20億次試驗Cohort b的初步高級結果，展示了26名腫瘤無PD-L1表達患者的ORR爲26.9％，DCR爲57.7％，這比歷史對照更好。
股價表現：截至上週五，IMMP股票在盤前交易時上漲了19.4％，至2.39美元。
