{"id":10745,"date":"2025-05-07T14:51:58","date_gmt":"2025-05-07T18:51:58","guid":{"rendered":"https:\/\/lifescivoice.com\/?p=10745"},"modified":"2025-05-07T14:51:58","modified_gmt":"2025-05-07T18:51:58","slug":"new-data-positions-immuteps-immunotherapy-combo-as-first-line-option-for-pd-l1-negative-hnscc","status":"publish","type":"post","link":"https:\/\/lifescivoice.com\/new-data-positions-immuteps-immunotherapy-combo-as-first-line-option-for-pd-l1-negative-hnscc\/","title":{"rendered":"New Data Positions Immutep\u2019s Immunotherapy Combo as First-Line Option for PD-L1-Negative HNSCC"},"content":{"rendered":"<p>Immutep, the developer of eftilagimod alpha, has reported promising overall survival (OS) results that could pave the way for regulatory approval in first-line head and neck cancer treatment.<\/p>\n<p>In a Phase 2b trial (Keynote-C34, also known as TACTI-003), Immutep demonstrated that combining eftilagimod with Merck &#038; Co.\u2019s checkpoint inhibitor Keytruda helped patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) \u2014 specifically those with low PD-L1 expression (combined positive score [CPS] <1) \u2014 achieve a median overall survival of 17.6 months when used as first-line therapy.\n\nThese results come from Cohort B of the study, which included 31 patients. Notably, the trial did not include a direct active control group. According to Immutep, the 17.6-month median survival exceeds historical benchmarks from standard-of-care treatments. Jefferies analyst David Stanton described the annual survival results as \u201cimpressive\u201d in a statement.\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script> <ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins> <script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script><br \/>\nImmutep plans to engage with the FDA to discuss potential approval of eftilagimod for first-line treatment of PD-L1-negative HNSCC, supported by its existing fast-track designation. CEO Marc Voigt confirmed that the company will meet with regulatory authorities to evaluate next steps toward potential approval of eftilagimod in combination with Keytruda.<\/p>\n<p>This combination therapy presents a unique value proposition: it offers a chemotherapy-free immunotherapy alternative for PD-L1-negative patients, a group currently limited to chemo-based options. Eftilagimod, a LAG-3 fusion protein, activates antigen-presenting cells to boost immune response, according to Immutep.<\/p>\n<p>The FDA first approved Keytruda with chemotherapy for initial HNSCC treatment in 2019, including patients with PD-L1-negative tumors. That approval was based on data showing a 23% reduction in mortality risk compared to Eli Lilly\u2019s EGFR inhibitor Erbitux combined with chemotherapy, across all PD-L1 expression levels. Keytruda was also approved as a standalone treatment, but only for patients with CPS \u22651.<\/p>\n<p>Post hoc analysis from the Keynote-048 trial revealed worse outcomes for PD-L1-negative patients treated with Keytruda and chemotherapy compared to Erbitux and chemotherapy. Median OS was 11.3 months for the Keytruda-chemo group vs. 10.7 months for Erbitux-chemo. Moreover, the risk of death was 21% higher in the Keytruda-chemo group for PD-L1-negative patients. However, researchers cautioned that the sample size for this subgroup was too small to draw definitive conclusions.<br \/>\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script> <ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins> <script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script><br \/>\nAgainst this backdrop, the 17.6-month median OS seen with the eftilagimod-Keytruda combination stands out, even though cross-trial comparisons should be interpreted cautiously.<\/p>\n<p>These new survival data build on previous tumor response findings. Immutep earlier reported an objective response rate (ORR) of 35.5% in Cohort B of TACTI-003, including a 12.9% complete response rate. For comparison, Keynote-048 reported a 30.8% ORR and 2.6% complete response rate in the PD-L1-negative subgroup treated with Keytruda plus chemotherapy.<\/p>\n<p>Voigt emphasized that the potential of this combination lies in delivering durable responses and significant survival benefits for a patient population in urgent need of more effective and tolerable options.<br \/>\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script> <ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins> <script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script><br \/>\nImmutep is aiming to serve the PD-L1-negative HNSCC segment, which it estimates comprises about 20% of all first-line HNSCC cases. Voigt noted that no current trials are investigating chemotherapy-free treatment approaches for this specific group.<\/p>\n<p>Meanwhile, Keytruda continues to be evaluated in combination with other therapies. It is being paired with Exelixis&#8217; investigational tyrosine kinase inhibitor, zanzalintinib, in the Phase 3 STELLAR-305 trial, which targets only PD-L1-positive HNSCC patients. Separately, Merus is conducting the Phase 3 LiGeR-HN1 trial, assessing its EGFR\u00d7LGR5 bispecific antibody petosemtamab with Keytruda in PD-L1-positive first-line HNSCC patients. Petosemtamab holds FDA Breakthrough Therapy designation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Immutep, the developer of eftilagimod alpha, has reported promising overall survival (OS) results that could pave the way for regulatory approval in first-line head and neck cancer treatment. In a Phase 2b trial (Keynote-C34, also known as TACTI-003), Immutep demonstrated that combining eftilagimod with Merck &#038; Co.\u2019s checkpoint inhibitor Keytruda helped patients with recurrent or [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":10746,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[],"class_list":{"0":"post-10745","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-research-development"},"_links":{"self":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10745","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/comments?post=10745"}],"version-history":[{"count":1,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10745\/revisions"}],"predecessor-version":[{"id":10747,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10745\/revisions\/10747"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media\/10746"}],"wp:attachment":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media?parent=10745"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/categories?post=10745"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/tags?post=10745"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}