
Late-Stage Efti Clinical Development Updates
Pathway in Lung Cancer (anti-PD-1 combination with or without chemo)
Immutep is prioritising 1L NSCLC in terms of late-stage clinical strategy, based on compelling data, coupled with the large market opportunity and continued high unmet need for more durable and tolerable options. In combination with top selling drug in oncology, Keytruda®, efti has been delivering strong results, especially in patients known to respond less than optimally/sub-optimally to anti-PD-1 treatment (e.g. patients with negative or low PD-L1 expression levels). Immutep’s next steps in NSCLC will be shaped by the maturing TACTI-002 data, with additional data expected in Q4 2022 and feedback from regulatory authorities.
Initial results from Immutep’s ongoing INSIGHT-003 trial evaluating efti in combination with anti-PD-1 therapy and chemotherapy are also expected in Q4 2022. These results may help to further inform the design of our late-stage trial in 1L NSCLC.
Pathway in Head and Neck Cancer (anti-PD-1 combination)
Currently, 47/154 patients (approximately 30%) have been recruited into Immutep’s ongoing randomised Phase IIb TACTI-003 trial in 1L HNSCC. Recruitment is accelerating as further sites have been activated. The trial is being conducted in collaboration with Merck & Co., Inc., Rahway, NJ, USA (known as “MSD” outside the United States and Canada). Efti in 1L HNSCC has Fast Track designation by the FDA, which provides Immutep with access to more frequent meetings and communications with the FDA, and potentially enables Rolling Review of a Biologic License Application. In addition, Fast Track designation may provide Accelerated Approval and Priority Review if relevant criteria are met, for efti in HNSCC.
Pathway in Breast Cancer (chemo combination)
Immutep will continue with preparations for future clinical development in MBC, including engagement with the regulators, Contract Research Organisations and other stakeholders, each of which are progressing. Efti has shown encouraging clinical data in combination with chemotherapy in this indication, including statistically significant improvements in overall survival (OS) across several pre-defined subgroups. As such, MBC remains an attractive opportunity for efti.
Ultimately, Immutep will aim to obtain marketing authorisation of efti in multiple indications, positioning the Company, or a potential partner, strongly to fully exploit the compelling potential of this unique clinical candidate to help a wide range of cancer patients.
Upcoming Clinical Data Updates
Immutep plans to provide further clinical trial updates in Q4 2022, as follows:
| • | | more data from TACTI-002 in 1L NSCLC, |
| • | | first results from the INSIGHT-003 study, and |
| • | | an update from the TACTI-003 study. |
New Clinical Trials
In addition to Immutep’s current development program, the company is also engaged in discussions with a number of external parties to test efti in new settings. The expansion of clinical settings will help to further explore the potential of efti and enhance its value. A first example is the recently announced new Phase II