AIPAC final data as expected: Phase III supported with maintaining a Buy Rating (ASX:IMM) (Analysts: Dr Melissa Benson and Dr Shane Storey)

Dr Melissa Benson [e-mail] | Tel. [phone]	10 N ovember 2021
Dr Shane Storey [e-mail] | Tel. [phone]

Immutep Limited (IMM)

AIPAC final data as expected: Phase III supported

Announcement highlights

Immutep have released final overall survival (OS) data from the Phase IIb AIPAC study of their lead LAG-3 asset, Efti, in combination with paclitaxel chemotherapy in metastatic breast cancer patients (with HR+/HER2- subtype). The final OS data is incrementally positive from the latest published data with further gains in survival observed across the three patient subgroups of focus in the trial. The significant benefits with the addition of Efti

in these patient subgroups continues to support Immutep's plans for their registration global Phase III study (EU & US sites) which is currently in preparation (which has already received a positive opinion from EMA). Today's update is a positive for Immutep's breast cancer program.

Wilsons' view

Initial analysis

Table 1. Final Overall Survival (OS) data from the AIPAC Phase IIb study of Efti in combination with chemotherapy in metastatic HR+/HER2- breast cancer

	Me dia n O S be ne fit	NO TES
	Previous data	Updated FINAL data
Tota l popula tion	+2.7 months	+2.9 months	As expected, non- significant benefit
HR=0.83 (p=0.14)	HR=0.88 (p=0.197)	at total group level.
<6 5 ye a rs old	+7.1 months	+7 . 5 months	Benefit extended, significance
subgroup
HR=0.62 (p=0.012)	HR=0 . 6 6 (p=0 . 0 17 )	maintained.
Low monoc yte	+9.4 months	+19 . 6 months	Benefit extended, significance
subgroup	HR=0.47 (p=0.02)	HR=0 . 4 4 (p=0 . 0 0 8 )
maintained.
Lumina l B subgroup	Not reported	+4 . 2 months	Significant benefit seen. Follows PFS
HR=0 . 6 7 (p=0 . 0 4 9 )
benefit previously reported.

Source: Immutep

Significant OS benefit observed in three pre -defined subgroups; key to inform Phase III design. Importantly, we have seen the significan t clin ical benefit of the Efti combination maintained out to the final analysis that has incorporated 72.5% of events. The key patient trial subgroups (<65 years, Luminal B and Low monocyte) all showed significant benefit versus placebo and support Phase III trial progression. Hazard ratios (HR) in the ≥0.67 range signal a clear clinical benefit of the combination in these subgroups versus chemotherapy alone.

Total group OS benefit incrementally improved at final cut off but still didn't reach significance; not unexpect ed in ou r v ie w. We h ave seen a market overreaction we expect to the total population OS data not reaching significance (p=0.197). This result is not at all unexpectedin our view as noted in ourprior research, and we focus (as Immutep are) on the <65 years subgroup as the key patient cohort informing the registration Phase III trial patient inclusion and future approvable label.

Low monocyte subgroup of patients experienced an extreme benefit. We note an incredibly impressive benefit in patien ts with low mon ocyte count, with an additional 10months OS benefit since the last interim analysis (+19.6 months total, p=0.008). As we have previously discussed, we are unsure as to how to interpret this population and their relevance to an approvable label, notwithstanding how excellent the data is. Further mechanistic understanding of why Efti is so beneficial in these patients will be key to further development of Efti in broader cancer cohorts.

Reactionary share price movements provide a buying opportunity. We note the US market traded ADRs as being down overnight. We expect th is is due to cursory views of the total population data not hitting significance. We note this was never expected and statistically very unlikely given the interim data readout - hence we view the associated market movements as ill-informedas to understanding the clinical data and importantly how it supports progression into a Phase III study which we expect is focused on patients 65 years and under.

Wilsons Equity Research
Analy st(s) who own shares in the Company: n/a		Issued by Wilsons Advisory and Stockbroking Limited (Wilsons) ABN

68 010 529 665 - Australian Financial Services Licence No 238375, a participant of ASX Group and should be read in conjunction with the disclosures and disclaimer in this report. Important disclosures regarding companies that are subject of this report and an explanation of recommendations can be found at the end of this document.

10 November 2021 Alert

Immutep Limited

Earnings implications

Results as expected and support our modelling of Immutep's breast cancer program.

Investment view

We maintain our OVERWEIGHT rating and $0.91 risked price target on Immutep. Immutep is also a member of Wilsons' Conviction Insights.

Wilsons Equity Research

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10 November 2021 Alert

Immutep Limited

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