28.11.2018 13:43:42
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Immutep Limited (IMM-AU): Mature TACTI-mel data confirm interim look
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Immutep Limited (IMM-AU): Mature TACTI-mel data confirm interim look KEY TAKEAWAY Immutep presented additional data from its Phase I TACTI-mel trial testing lead asset eftilagimod alpha ("efti") in combination with anti-PD-1 Keytruda ("pembro") in advanced melanoma at the ICI Europe Summit in Berlin. Overall, the data is consistent with previously disclosed interim data. Importantly, there is a subset of patients that continues to enjoy long-lasting and durable responses, further supporting that combination therapy of an established checkpoint inhibitor with a novel immuno-oncology drug that has a complementary mechanism of action may be the key to increasing long-term response rates. The TACTI-002 trial testing the same combination in lung and head and neck cancers remains on track to start recruiting in early 2019E. The key catalyst for Immutep remains Phase IIb data for efti in metastatic breast cancer, expected in H2/2019E. Positive data would raise our target price ("TP") by 43%. We maintain and reiterate both our OUTPERFORM recommendation and AUD0.078 target price. Mature TACTI-mel data confirms interim data, including durable responses Immutep presented two sets of data from the TACTI-mel trial: (1) Mature data for Part A (18 patients), where efti is added to pembro after 4 cycles of monotherapy in patients with suboptimal responses to pembro, and (2) first data from Part B (6 patients), where efti is added to pembro from the start. The overall response rate ("ORR") for Part A patients was 33% when measured from the start of combination therapy and 61% when measured from the start of pembro therapy, which is consistent with interim data of 33% and 61%, respectively. Importantly, 5/18 patients (28%) had responses lasting >12 months and up to 27 months, including one complete response ("CR"). In Part B, first data showed an encouraging ORR of 50% and a disease control rate of 66%, despite patients having a very poor prognosis (100% M1c status). TACTi-002 trial to start recruiting in early 2019E The TACTI-002 trial will test efti 30mg (highest dose from the TACTI-mel trial) plus pembro in up to 110 patients with advanced lung (1st and 2nd line) or head & neck cancer (2nd line). Earlier this month Immutep announced that the site selection process had been completed, meaning that the first patient may be recruited in early 2019E. Together these indications account for c.20% of our TP for Immutep, based on launch in 2025E and combined peak sales of $2.1bn.
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Equity Research Analysts - Martin Brunninger, Brigitte de Lima, Chris Redhead and Martin Piehlmeier.
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