{"id":50400,"date":"2022-11-02T18:02:11","date_gmt":"2022-11-02T17:02:11","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/transgene-announces-positive-interim-analysis-results-of-phase-ii-trial-evaluating-tg4001-avelumab-vs-avelumab-in-hpv-positive-anogenital-cancers\/"},"modified":"2022-11-02T18:02:11","modified_gmt":"2022-11-02T17:02:11","slug":"transgene-announces-positive-interim-analysis-results-of-phase-ii-trial-evaluating-tg4001-avelumab-vs-avelumab-in-hpv-positive-anogenital-cancers","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/transgene-announces-positive-interim-analysis-results-of-phase-ii-trial-evaluating-tg4001-avelumab-vs-avelumab-in-hpv-positive-anogenital-cancers\/","title":{"rendered":"Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers"},"content":{"rendered":"
\n

\nBased on promising progression-free survival (PFS) interim analysis, trial to continue and an optimized number of patients to be randomized in the trial<\/b>\n<\/p>\n

<\/a><\/p>\n

\nManagement to host webcast presentation of the interim results today, November 2, 2022 at 6 p.m. CET \/ 1 p.m. EST<\/b>\n<\/p>\n

STRASBOURG, France–(BUSINESS WIRE)–#HBV<\/a>–Regulatory News:\n<\/p>\n

\nTransgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, today announces that following an interim analysis of its randomized controlled Phase II clinical study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV16-positive anogenital tumors <\/b>(NCT: 03260023<\/a>), the Independent Data Monitoring Committee (IDMC) has recommended the study continue.
\n
<\/b>Based on positive signals observed in the interim analysis, the trial is now expected to enroll an additional 66 patients, for a total trial size of 120 patients compared to the previously announced target of 150 patients. Transgene anticipates the last patient to be randomized in the trial <\/b>in H1 2024.<\/b>\n<\/p>\n

\nHedi Ben Brahim, CEO, and Dr. Maud Brandely, Chief Medical Officer, MD, PhD, will host an analyst and investor call to discuss the interim analysis at 6:00 pm CET (1:00 pm EST) today (see details below).\n<\/p>\n

\nThe Phase II study is evaluating TG4001, an investigational therapeutic cancer vaccine, in combination with avelumab compared to avelumab alone in patients with HPV16-positive anogenital tumors without liver metastases, through a continuing collaboration with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab.\n<\/p>\n

\n\u201cWe are very pleased with the outcome of this interim analysis,\u201d said Hedi Ben Brahim, Chief Executive Officer of Transgene.<\/b> \u201cThe IDMC\u2019s recommendation to continue the study reinforces our confidence in TG4001, which follows promising data from our earlier Phase Ib\/II trial. This also enables us to reduce the number of patients randomized in the trial. We are looking forward to completing this trial in H1 2024 and communicating its results when they are available. We expect that positive final results from this trial will allow us to launch a registration trial to further confirm the benefit of our therapeutic vaccine candidate. TG4001 aims to provide a new solution to patients who currently have very limited treatment options.\u201d\n<\/p>\n

\nThe interim analysis was triggered per protocol, by a predefined number of PFS events. Based on the interim results, the IDMC\u2019s objective was to provide a recommendation on the continuation of the trial and on the final sample size using adaptive sample size re-estimation modeling approach.
\n
To date, the treatment has been well tolerated. Adverse events are consistent with previous observations made in the Phase Ib\/II trial.\n<\/p>\n

\nTG4001 is based on a MVA (Modified Vaccinia Ankara) vector, which is engineered to express HPV16 antigens (E6 & E7) and interleukin 2 (IL-2). TG4001 is designed to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens that can be found in HPV16-related tumors and to induce a specific cellular immune response against these cancer cells.\n<\/p>\n

\nPhase II trial aims to show superiority <\/b>of TG4001 + avelumab over avelumab monotherapy<\/b>\n<\/p>\n

\nThe trial is enrolling patients in the USA and in Europe (France and Spain). It focuses on patients with recurrent or metastatic HPV16-positive anogenital cancer without liver metastases, including cervical, vulvar, vaginal, penile, and anal cancer. Patients are randomized to either receive the combination regimen of the therapeutic vaccine TG4001 and avelumab or avelumab alone.\n<\/p>\n

\nThe primary endpoint of the trial is progression-free survival (PFS) according to RECIST 1.1. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS) and a series of immunological parameters.\n<\/p>\n

\nA conference call in English<\/b> is scheduled today, on November 2, 2022, at 6 p.m. CET \/ 1 p.m. EST.\n<\/p>\n

\nWebcast link to English language conference call:
\n
<\/i><\/b>https:\/\/channel.royalcast.com\/landingpage\/transgene\/20221102_1\/<\/a>\n<\/p>\n

\nParticipant telephone numbers:<\/i><\/b>\n<\/p>\n\n\n
\n

\nFrance: +33 (0) 1 70 37 71 66\n<\/p>\n

\nUnited Kingdom: +44 (0) 33 0551 0200\n<\/p>\n

\nUnited States: +1 212 999 6659\n<\/p>\n<\/td>\n

\u00a0<\/td>\n\u00a0<\/td>\n\n

\nConfirmation code: Transgene\n<\/p>\n

\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nA replay will be available on the Transgene website (www.transgene.fr<\/a>) following the live event.\n<\/p>\n

\nAbout the trial
\n
<\/i><\/b>The multi-center, open label, randomized Phase II trial (NCT03260023) is designed to compare the efficacy of the combination of TG4001 and avelumab versus avelumab alone in patients with advanced, recurrent and\/or metastatic HPV16-positive anogenital cancers who have disease progression after a maximum of one line of systemic treatment, or who are not eligible for first-line chemotherapy.\n<\/p>\n

\nProf. Christophe Le Tourneau, M.D., PhD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute, is the Principal Investigator of the study. The trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE), which are providing avelumab for the trial. Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. Transgene will continue to be the sponsor of the trial and conduct the trial. Avelumab is not approved alone or in combination for the treatment of HPV16-positive anogenital tumors in any region.\n<\/p>\n

\nPatients will receive TG4001 at the dose of 5×107<\/sup> pfu, SC, weekly for 6 weeks, every 2 weeks up to six months, and every 12 weeks thereafter, in combination with avelumab or avelumab alone at 800 mg, IV every two weeks, until disease progression. The primary endpoint of the trial is progression-free survival (PFS) according to RECIST 1.1. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS) and other immunological parameters. The trial will enroll 120 patients.\n<\/p>\n

\nAbout the Phase Ib\/II data of TG4001 + avelumab (single arm trial)
\n
<\/i><\/b>The combination of TG4001 and avelumab demonstrated anti-tumor activity (22% ORR)<\/b> in patients with previously treated recurrent and\/or metastatic HPV-related cancers (including patients with oropharyngeal cancers and anogenital cancers). Presence of liver metastases had a profound impact on the outcome in terms of ORR and PFS<\/b>. In patients without liver metastases, an ORR of 32%, a median PFS of 5.6 months and a median OS of 13.3 months were achieved. <\/b>The treatment induced HPV-specific T-cell responses and was associated with increased levels of immune cell infiltration in the tumors and expression of genes associated with activation of the immune system. The results from the Phase Ib\/II parts of the trial combining TG4001 with avelumab in HPV16-positive recurrent and\/or metastatic malignancies have been updated in a R&D day held in September 2022 by Transgene. A first set of data had been presented at SITC 2020 and ESMO IO 2020 [1,2]<\/sup>.\n<\/p>\n

\nAbout TG4001
\n
<\/i><\/b>TG4001 is an investigational therapeutic vaccine based on a non-propagative, highly attenuated Vaccinia vector (MVA), which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2). TG4001 is designed to have a two-pronged antiviral approach: to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens, that can be found in HPV16-related tumors, and to further stimulate the infection-clearing activity of the immune system through interleukin 2 (IL-2). TG4001 has been administered to more than 350 individuals, demonstrating good safety and promising efficacy results [1, 2,]<\/sup>. Its mechanism of action and good safety profile make TG4001 an excellent candidate for combinations with other therapies in HPV-mediated solid tumors.\n<\/p>\n

\nAbout Transgene
\n
<\/i><\/b>Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene\u2019s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.
\n
The Company\u2019s clinical-stage programs consist of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac<\/i>\u00ae platform) as well as two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO\u2122 platform).
\n
With Transgene\u2019s myvac<\/i>\u00ae platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac<\/i>\u00ae approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.
\n
With its proprietary platform Invir.IO\u2122, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO\u2122 collaboration with AstraZeneca.
\n
Additional information about Transgene is available at: www.transgene.fr<\/a>. Follow us on Twitter: @TransgeneSA<\/a>\n<\/p>\n

\nTransgene disclaimer
\n
<\/i><\/b>This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company\u2019s activities, perspectives, financial situation, results, regulatory authorities\u2019 agreement with development phases, and development. The Company\u2019s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and\/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company\u2019s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (\u201cFacteurs de Risque\u201d) section of the Universal Registration Document, available on the AMF website (http:\/\/www.amf-france.org<\/a>) or on Transgene\u2019s website (www.transgene.fr<\/a>). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.<\/i>\n<\/p>\n

\nReferences<\/i><\/b>\n<\/p>\n

\n[1] Le Tourneau et al. \u201cTG4001 (Tipapkinogene sovacivec) and avelumab for recurrent\/metastatic (R\/M) Human Papilloma Virus (HPV)-16+ cancers: clinical efficacy and immunogenicity.\u201d 2020 SITC Annual Meeting<\/a>, 9-11 November 2020, Poster presentation
\n
[2] Le Tourneau et al. \u201cTG4001 therapeutic vaccination combined with PD-L1 blocker avelumab remodels the tumor microenvironment (TME) and drives antitumor responses in Human PapillomaVirus (HPV)+ malignancies.\u201d2020 ESMO IO meeting, 12 December 2020, mini-oral presentation\n<\/p>\n

Contacts<\/b> <\/p>\n

\nTransgene:<\/b>
Lucie Larguier<\/b>
Director Corporate Communications & IR
\n
+33 (0)3 88 27 91 04
\n
investorrelations@transgene.fr<\/a>\n<\/p>\n

\nMedia Transgene:<\/b>
MEDiSTRAVA Consulting<\/b>
David Dible\/Sylvie Berrebi\/ George Underwood<\/b>
+44 (0)203 928 6900
\n
transgene@medistrava.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Based on promising progression-free survival (PFS) interim analysis, trial to continue and an optimized number of patients to be randomized in the trial Management to host webcast presentation of the interim results today, November 2, 2022 at 6 p.m. CET \/ 1 p.m. EST STRASBOURG, France–(BUSINESS WIRE)–#HBV–Regulatory News: Transgene (Euronext Paris: TNG), a biotech company … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-50400","6":"format-standard","7":"category-industry"},"yoast_head":"\nTransgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/transgene-announces-positive-interim-analysis-results-of-phase-ii-trial-evaluating-tg4001-avelumab-vs-avelumab-in-hpv-positive-anogenital-cancers\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Based on promising progression-free survival (PFS) interim analysis, trial to continue and an optimized number of patients to be randomized in the trial Management to host webcast presentation of the interim results today, November 2, 2022 at 6 p.m. CET \/ 1 p.m. EST STRASBOURG, France–(BUSINESS WIRE)–#HBV–Regulatory News: Transgene (Euronext Paris: TNG), a biotech company ... 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