Head and Neck Cancer Highlights : ASCO 2021

DelveInsight is tracking all the movements, big and small, being made in the ASCO21. We bring you some of the most exciting abstracts presented at ASCO21 Day 2 revolving around Head and Neck Cancers. Continue to know more. 

Abstract #6028: Emergence of LAG-3 Immunotherapy, Eftilagimod alpha- in combination with Pembrolizumab in Second-line HNSCC 

TACTI-002 (Two ACTive Immunotherapies) is a Phase II clinical trial being conducted by Immutep in collaboration with Merck. Immutep, one of the global leaders developing LAG-3 immunotherapy, has already kept a clear distinction when it comes to its LAG-3 Immunotherapy, Eftilagimod alpha (Efti) which is a soluble version of LAG-3 activating Antigen Presenting Cells (APCs) and works oppositely when compared to the existing anti-LAG3 antibodies such as BMS's Relatlimab. The ongoing ASCO 2021 presented positive results from a phase II study of Efti- Pembrolizumab combination in patients with PD-L1 unselected metastatic second-line squamous head and neck carcinoma (HNSCC). 

The study had evaluated 183 patients with data cut-off till 16th April 2021. All of them were pre-treated with platinum-based chemotherapy. Encouraging ORR of 30% in patients unselected for PD-L1 with 13.5 % complete responses were observed. Responses were durable, with median DOR not yet reached. In patients with PD-L1 CPS ≥1, ORR was 45.8 %, median PFS of 4.1 months and median OS of 12.6 months. Efficacy in PD-L1 CPS ≥1 encouraging compared to KN-040 (PIII, randomized trial). It was great to know that there were no adverse reactions leading to treatment discontinuation. 

Expert Views: 

"The results from this trial, and our other trials, continue to support our hypothesis that the combination of eftilagimod alpha, with a PD-1 inhibitor such as pembrolizumab should result in a meaningful benefit to patients across various cancers."

"Immutep is seemingly well situated for potential takeout or large biobucks deal(s)."

Efti- Pembrolizumab combination is safe and shows encouraging antitumor activity in platinum pre-treated 2nd line HNSCC patients. These encouraging results have led to the commencement of another Phase II study in 1st line HNSCC.

Abstract #6036: Inconsistent data from Amgen and Merck's phase Ib study in recurrent/metastatic HNSCC patients, leading to discontinuation of the study

Amgen, in collaboration with Merck, presented the safety and preliminary efficacy of Imlygic (Talimogene Laherparepvec) plus Keytruda (Pembrolizumab) in patients with R/M HNSCC in a phase Ib–MASTERKEY232/ KEYNOTE-137 (NCT02626000) study. 

Among a total of 36 patients enrolled, objective ORR was seen in 16.7% of participants. The DCR was 38.9%, the median OS was 5.8 months, and the median PFS was 3 months. Among the patients who observed the response, the median duration of the response was nearly 4 years. Additionally, the safety results at 3 yrs for T-VEC plus pembro in patients with R/M HNSCC were consistent. Regrettably, the overall response rate did not meet the prespecified criterion to proceed to a further randomized evaluation of this combination, and the study was discontinued.

However, as per previously reported results, the combination demonstrated a tolerable safety profile in R/M HNSCC. Considering the latest disappointing results, let's wait to see what the company has in plans for the future in this indication.

We have covered Day1 ASCO and we are continuing to do so as the conference picks up its pace. Catch us at the ASCO2021 Event.