Good day, and thank you for standing by. Welcome to the Transgene conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Lucie Larguier, CFO. Please go ahead.
Thank you, Sonia, and hello, everyone. Thanks for joining us today on this call. I'm Lucie Larguier, Chief Financial Officer at Transgene. I am today with Dr. Alessandro Riva, our Chairman and CEO at Transgene, and we will be available to you until 4:00 P.M. CET, which makes our call 30 minutes long. Today, we'll discuss the recent update on the TG4001 randomized phase 2 clinical trial in advanced and metastatic HPV-16-positive cervical and anogenital cancers. We will provide our view on the top line results before we take and answer your question. Before I turn the call over to Dr. Riva, I'd like to remind everyone that today's discussion contains forward-looking statements, which are subject to numerous risks and uncertainties. If you're listening to this live webcast via the Internet, you will not be able to ask questions after Alessandro's statements.
If you wish to ask questions, please make sure you join us via one of the conference call numbers that are available in today's press release. You can also directly send me an email to investor.relations@transgene.fr, and I will be happy to read your question. With this, I now turn the call over to Dr. Riva.
Thank you, Lucie. Good afternoon, everyone, and thank you for joining this call. The objective of today's call is to walk through the press release on the results of the randomized phase two study, evaluating TG4001, to share the next step and to answer your question. The study compared the TG4001 in combination with avelumab versus avelumab monotherapy in recurrent or metastatic cervical and anogenital cancer. The primary objective was improvement in progression-free survival in the overall patient population. Secondary objectives were overall response rate, duration of response, and survival. Predefined subgroup analyses were also planned to assess the efficacy and safety in cervical cancer, anal cancer, and genital cancer subgroups. 100 patients have been enrolled in the trial, of whom 90 who did not have liver metastasis were analyzed.
54% were cervical cancer patients, 30% anal cancer, and 16% genital cancer. The analysis on the 10 patients with liver metastasis has not yet been performed and will be disclosed with the full analysis of the trial. Patients had recurrent or metastatic disease, and around 75% of them received one prior line of systemic therapy, including chemotherapy and targeted agents for recurrent or metastatic disease. All patients were checkpoint inhibitors naive. As announced this morning, the trial did not meet the primary objective in the overall patient population. However, in a preplanned analysis, an efficacy trend in favor of TG4001-containing regimen was observed in the cervical cancer patients group. That, as I said, represent 54% of the total patients enrolled in the study. This trend requires further confirmation through additional analysis, including by tumor PD-L1 status.
TG4001 was well tolerated, with adverse events consistent with prior observations. We are currently analyzing the full dataset, and we plan to communicate the complete analysis, including the correlative science data, at an international conference that will be held during the first semester of 2025. Our goal remains to determine the best possible path forward for the TG4001, particularly in cervical cancer, where we saw an efficacy trend and also considering the evolving treatment landscape. I would like to take a moment to express our gratitude to the patients, clinicians, caregivers, as well as the Transgene teams who contributed in this study. Transgene remains focused on advancing its pipeline of innovative immunotherapies with a cash runway until Q4 2025.
In particular, at the Society for Immunotherapy of Cancer conference that will be held in Houston in November, we will be presenting twenty-four-month median follow-up data from the randomized phase one study of our individualized cancer vaccine, TG4050, in the adjuvant setting of HPV-negative head and neck cancer patients. Thank you for your attention, and we'll now open up for questions.
Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Once again, to ask a question, please press star one one and wait for your name to be announced. To withdraw your question, please press star one one again. As there are no further questions, I would like to hand back to Alessandro Riva for any closing remarks.
Thank you for your participation in this call. We will keep you informed on our progress, and I hope that we can meet with some of you in Houston, Texas, to discuss the updated data of TG4050 in head and neck cancer. Thank you and a great day.
This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.