Wilsons Equity Research - No longer a need to weigh up chemo; Maintain Overweight (Analysts: Dr Melissa Benson and Dr Shane Storey)

Date	Theme	Sector
17 May 2023	Alert	Healthcare
		Company

Immutep Limited (IMM)

No longer a need to weigh up chemo

• Announcement Highlights

Immutep have released Overall Survival (OS) data from their Phase II TACTI-002 trial in 1L non- small-cell lung cancer (NSCLC). Initial median OS of 25 months with a combination of Efti + pembrolizumab in those with PD-L1 positive tumours (TPS ≥1%) compares very favourably with other 1L options, be it anti-PD-1 monotherapy (Keytruda: 16.7 months; Opdivo: 13.4 months) or anti-PD-1 combinations with chemotherapy (Keytruda: >15.9 months) or other checkpoint inhibitors (anti-CTLA-4: 17.1 months) - from registrational trials in comparable TPS populations (Figure 1). The confirmed OS benefit compared to existing IO agent(s) (± chemotherapy), should distinguish the Efti + Keytruda combo as the initial go-to in clinician's minds (subject to confirmation by randomised clinical trials). This OS data suggests clinicians many no longer need to weigh up incremental survival benefit with add-on chemo, and associated side effect burden, with the Efti combination able to deliver on OS (matching/bettering chemo) with a superior tolerability profile. This is compelling and we expect IMM to be a hot topic of discussion at ASCO in a few weeks' time (June 2-6th), having demonstrated such impressive OS data in the absence of chemotherapy.

Recommendation	OVERWEIGHT
12-mth target price (AUD)	$0.91

Dr Melissa Benson

[e-mail]

Tel. [phone]

Dr Shane Storey

[e-mail]

Tel. [phone]

Madeleine Williams

[e-mail]

Tel. [phone]

• Wilsons' View

Initial analysis

Figure 1: Comparison of TACTI-002 response in 1L NSCLC vs other IO/chemo 1L trials

Ta rg e ts

FDA a p p ro va l

Stu d y

Ph a se

Th e ra p y L in e n

PD- L 1 TPS <1%

TPS 1- 4 9 %

TPS ≥ 5 0 %

Me d ia n PFS (a ll PD- L 1)

Me d ia n OS (mo n th s) fo r TPS ≥ 1%

Do R me d ia n ORR (a ll PD- L 1)

Re sp o n se c rite ria

Ad ve rse Eve n ts (AEs)

Discontinuation AEs

Efti +			Ate zo lizu ma b	Pe mb ro +	Nivo lu ma b +
p e mb ro lizu ma b		Pe mb ro lizu ma b	+ tira g o lu ma b	c h e mo	ip ilimu ma b	Nivo lu ma b
APC activator +		Anti-PD-1	Anti-PD-L1+	Anti-PD-1+	Anti-PD-1+	Anti-PD-1
	Anti-TIGIT	chemo	Anti-CTLA-4
Anti-PD-1
-		April 2019	-	Oct 2018	May 2020	2L: 2015
						Ch e c kma te -
TACTI- 0 0 2		Ke yn o te - 0 4 2	CITYSCAPE	Ke yn o te - 4 0 7	Ch e c kma te - 2 2 7	0 17 /0 5 7 p o o le d
						a n a lysis
II		III	II	III	III	III
1st		1st	1st	1st	1st	1st
114	637	67	278	396	427
28%		n il	57%	34%	32%	38%
33%	53%	37%	33%	43%
18%	47%	43%	26%	35%	19%
6.9 m		5.4 m	5.6 m	6.4 m	7.2 m	2.3- 3.5m
2 5 . 0 m		16.7m	23.2m	15.9 m	17.1m	13.4m
21.6 m		20.2 m	17.6m	7.7 m	19.6 m	17.2- 25.2 m
4 0 %	27%	39%	58%	33%	19- 20%
iRECIST		RECIST v1.1	RECIST v1.1	RECIST v1.1	RECIST v1.1	RECIST v1.1
10%	8%	15%	23%	18%	6%

Source: per footnotes overleaf, IMM.

Roche TIGIT overhang could impact excitement. We remember back to the readout from Roche's Phase II CITYSCAPE trial combining anti-PD-1(atezolizumab) with their anti-TIGITasset (tiragolumab) where they previewed data that was similar/as compelling as Immutep's (median OS: 23.2 months; ORR 39%; DoR 17.6 months). This created excitement in the IO market, heralding this new anti-TIGITas the next IO revolution. Since, with the advent of several failed Phase III trials with the tiragolumab combo (noting that Roche continue to progress the asset), the markets positivity toward new IO-IOcombos may have dampened. Of course, the readthrough between Roche's experience and Immutep's are not at all related (different target). We simply assess the market has had recent expectations for a new IO combo dulled, and hence IMM is not experiencing the full extent of investor excitement this new OS data should warrant, in our view.

Wilsons Equity Research

Analyst(s) who owns 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.

17 May 2023

Earnings implications

Incremental de-risking of the NSCLC program as it heads into a registrational trial later this year. No changes to our forecasts/model assumptions.

Investment view

Maintain our OVERWEIGHT recommendation and $0.91/sh risked PT on Immutep.

Footnote references:

Brahmer et al. 2015. Nivolumab versus Docetaxel in Advanced Squamous-CellNon-Small-Cell Lung Cancer. NEJM. 373: 123-135.

Cho B et al. 2022. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selectednon-small cell lunch cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncology. 23 (6): 781-792.

Hellman M et al. 2019. Nivolumab plus ipilimumab in advanced non-small-cell lung cancer. NEJM. 381: 2020-2031.

Horn L et al. 2017. Nivolumab Versus docetaxel in previously treated patients with advanced non-small-cell lung cancer: Two year

outcomes from two randomised, open-label, Phase III trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 35(35): 3924-3933.

Mok T et al. 2019. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing,locally-advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 10183: 1819-1830.

Paz-Ares L et al. 2018. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. NEJM. 379: 2040-2051.

Wilsons Equity Research

Healthcare Immutep Limited

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17 May 2023	Healthcare
	Immutep Limited

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