On June 3, 2024 IDEAYA Biosciences, Inc. (the "Company") reported clinical data from the ongoing investigator-sponsored Phase 2 trial of darovasertib, the Company’s oral, small molecular inhibitor of protein kinase C (or PKC), as neoadjuvant/adjuvant treatment in uveal melanoma (or UM) (Press release, Ideaya Biosciences, JUN 3, 2024, View Source [SID1234644013]). The clinical data from the trial were included in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting by Anthony Joshua, MBBS, PhD, FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent’s Hospital in Sydney, and the lead principal investigator of the Phase 2 study. The Company also announced preliminary clinical data from its Phase 2 trial of darovasertib for neoadjuvant UM.

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ASCO Clinical Data from Investigator-Sponsored Phase 2 Trial:

Fifteen patients planned for enucleation with localized UM were treated with darovasertib 300mg twice daily. An initial safety cohort of three patients were treated for one month, and the remaining 12 patients were treated in an expansion cohort for up to six months as neoadjuvant treatment prior to their primary intervention (enucleation, plaque brachytherapy or external beam radiotherapy (EBRT)) across three Australian centers.

As of the database lock on May 14, 2024, 13 patients had completed neoadjuvant treatment, 11 patients received adjuvant darovasertib after primary treatment of their UM, with five patients completing the planned six months of therapy. As of May 14, 2024, 75% (9 out of 12 enucleation patients) had confirmed Eye Saved (i.e., converted to plaque brachytherapy or EBRT) and approximately 67% (8 out of 12 enucleation patients) observed greater than 30% tumor shrinkage (maximum volume change) after 6 months. Median tumor shrinkage (maximum volume change) in 12 enucleation patients was approximately 47% after 6 months.

The darovasertib monotherapy neoadjuvant treatment had a manageable adverse event (AE) profile with no drug-related serious adverse events observed. Drug-related AEs were predominantly Grade 1 or Grade 2 and 20% of patients reported at least one drug-related Grade 3 adverse event.

Phase 2 Company-Sponsored Trial Data:

As of May 24, 2024 cut-off date, the Phase 2 company-sponsored darovasertib neoadjuvant UM trial has activated over 14 sites globally and enrolled over 40 patients. As of the cut-off date, 8 patients (6 enucleation and 2 plaque eligible) have been on darovasertib treatment for 4-months or more and observed median tumor shrinkage (maximum height/base/volume change) of approximately 40%/25%/72% and the majority of the 6 enucleation patients had reported Eye Saved (i.e., converted to plaque brachytherapy or EBRT eligible).

In the 8 patients with 4-months or more of darovasertib treatment as of May 24, 2024, darovasertib had a manageable AE profile with no drug-related serious adverse events observed, and drug-related AEs were predominantly Grade 1 or Grade 2 and approximately 13% of patients reported at least one drug-related Grade 3 AE.

On June 3, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that results from FRUTIGA, HUTCHMED’s Phase III trial of fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric cancer in China, were published in Nature Medicine (Press release, Hutchison China MediTech, JUN 3, 2024, View Source [SID1234644012]). Updated efficacy data in key subgroups and data on quality of life (QoL) within this publication were also presented on June 1 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") 2024 Annual Meeting.

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Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors ("VEGFRs") 1, 2 and 3. It works as an anti-cancer therapy by blocking tumor angiogenesis, a proliferation of blood vessels that is critical for cancer growth. The VEGFR pathway plays a key role in the pathogenesis of gastric cancer, which is the fifth most common malignant cancer worldwide, with 1.1 million new cases per year1. The FRUTIGA trial results published by Nature Medicine suggest that fruquintinib could be another effective treatment option for gastric cancer patients.

FRUTIGA was a 1:1 randomized, double-blind, Phase III study conducted across 35 sites in China (NCT03223376). It evaluated fruquintinib in combination with paclitaxel chemotherapy, compared with paclitaxel monotherapy, for second-line treatment in 703 patients with advanced gastric or gastroesophageal junction adenocarcinoma. The study was declared positive due to a statistically significant improvement in progression-free survival ("PFS"), one of two dual primary endpoints. Median PFS for patients who received fruquintinib plus paclitaxel was 5.6 months, compared to 2.7 months for those who received paclitaxel monotherapy (stratified hazard ratio ["HR"] = 0.569; p < 0.0001). An improvement was also observed in the dual primary endpoint of median overall survival ("OS"), (9.6 months vs. 8.4 months) but this was not statistically significant. Fruquintinib plus paclitaxel demonstrated statistically significant improvements in multiple other endpoints including objective response rate ("ORR"), disease control rate (DCR) and duration of response (DoR). It was well tolerated, with a safety profile consistent with expectations and previously reported studies.2

In further analysis of key subgroups presented at ASCO (Free ASCO Whitepaper), PFS and OS results were consistent with the primary analysis compared to the intention-to-treat (ITT) population. There was a clear PFS benefit observed for fruquintinib plus paclitaxel in the majority of subgroups, with particular benefit in both PFS and OS in the intestinal-type and lymph node metastasis subgroups. An exploratory post-hoc analysis for patients with lymph node metastasis revealed superior benefits of fruquintinib versus placebo in PFS, OS, ORR, disease control rate and duration of response. A possible mechanism for this effect is fruquintinib’s potent inhibition of VEGFR­-3, which is closely linked to lymph node metastasis and tumor invasion. Further analysis of patient-reported quality of life ("QoL") revealed no adverse impact on QoL at end of treatment compared to current standard of care. Together, these additional findings, alongside previously reported results, support fruquintinib plus paclitaxel as another treatment option in this indication.

Key results from FRUTIGA were previously disclosed at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series Session on February 6, 2024, with the full presentation available here.3

Fruquintinib is approved in China and the United States for the treatment of certain patients with metastatic colorectal cancer ("CRC"). A New Drug Application ("NDA") for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma in China was accepted for review by the China National Medical Products Administration (NMPA) in April 2023.

About Gastric Cancer

Gastric cancer is a cancer that starts in the stomach. It is the fifth most common cancer worldwide in 2020. It was estimated to have caused approximately 770,000 deaths worldwide.4 In China, it was estimated that over 478,000 people were diagnosed with gastric cancer, and approximately 374,000 people died from gastric cancer.5

About Fruquintinib

Fruquintinib is a selective oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for its potential use as part of combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combinations with other anti-cancer therapies.

About Fruquintinib Approval in China

In China, fruquintinib is co-developed and co-marketed by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. The approval was based on data from the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, which were published in the Journal of the American Medical Association, JAMA. Since its launch in China and as of mid-2023, more than 80,000 colorectal cancer patients have been treated with fruquintinib.

About Fruquintinib Approval in the U.S.

Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. Fruquintinib received approval in the U.S. in November 2023, where it is marketed by Takeda under the brand name FRUZAQLA. The approval was based on data from two large, randomized, controlled Phase III trials: the multi-regional FRESCO-2 trial, data from which were published in The Lancet, along with the FRESCO trial conducted in China, showing consistent benefit among a total of 734 patients treated with fruquintinib. Safety profiles were consistent across trials. Please see FRUZAQLA full Prescribing Information here.

On June 3, 2024 Grey Wolf Therapeutics, a clinical-stage biotechnology company leveraging first-of-its-kind antigen modulation therapies to address the source of immune dysfunction in oncology and autoimmunity, reported that initial data from the company’s ongoing adaptive Phase 1/2 clinical trial of GRWD5769, an investigational first-in-class ERAP1 inhibitor, were reported in a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Grey Wolf Therapeutics, JUN 3, 2024, View Source [SID1234644011]). The presented data consisted of preliminary findings from the initial repeat dosing monotherapy module of the study and demonstrated well-tolerated dose dependent target engagement following administration of escalating oral doses of GRWD5769. Importantly, the observed modulation of the human immunopeptidome with GRWD5769 provides clinical proof-of-mechanism for the novel immuno-oncology candidate and its foundational antigen modulation technology.

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"We are highly encouraged by the initial data from our ongoing study, highlighted by the achievement of success in the first known attempt to modulate the immunopeptidome for specific therapeutic purposes. These clear signs of target engagement provide compelling support for our antigen modulation strategy in immuno-oncology, which is designed to allow T cells to recognize new targets on tumour cells and drive de novo anti-tumour responses," said Tom Lillie, M.D., Ph.D., chief medical officer of Grey Wolf Therapeutics. "The presented data demonstrate a promising tolerability profile for GRWD5759 across all four dose levels administered to date, along with achievement of stable disease for a number of patients, some of whom have remained on treatment for nearly a year. These findings strongly support our recent initiation of combination dosing with GRWD5769 and cemiplimab, and our plans for further expansion cohorts in the near future."

Grey Wolf has developed and is advancing a unique immuno-oncology therapeutic strategy utilizing a proprietary antigen modulation strategy to reveal novel and potent cancer antigens on the surface of tumour cells. This is achieved through oral delivery of a targeted inhibitor of the endoplasmic reticulum aminopeptidases (ERAP1 or ERAP2), key proteins in the antigen presentation pathway. The targeted inhibition of ERAP is designed to elicit a de novo T cell response against tumours and to avoid T-cell exhaustion, thereby overcoming two key resistance mechanisms to current immuno-oncology therapy.

The company is evaluating this novel immuno-oncology approach through the EMITT-1 (ERAP Mediated Immunopeptide Targeting Trial – 1) Phase 1/2 clinical trial. The modular multi-part, multi-arm open-label study is designed to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of GRWD5769 alone and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with a range of solid tumour types.

Key takeaways from the EMITT-1 trial presented at ASCO (Free ASCO Whitepaper) include:

GRWD5769 was well tolerated, with predictable pharmacokinetics following repeat oral administration in all dose cohorts (up to 200 mg BID).
Dose-dependent target engagement as evidenced by modulation of the immunopeptidome.
Clinical proof-of-mechanism, confirming the expected mechanistic effects of ERAP1 inhibition and consistent with those seen in preclinical models.
Initial, early efficacy assessments demonstrating stable disease achieved by a number of patients, some of whom have remained on treatment for nearly a year.

The dose escalation portion of the trial continues as the company seeks to identify the recommended Phase 2 dose for GRWD5769. The company has also recently initiated dosing in the study’s first cohort combining GRWD5769 with immune checkpoint inhibition. Grey Wolf recently reported that it is expanding the scope of the study, allowing for the enrolment of patients with additional tumour types.

Further information about the EMITT-1 Phase 1/2 clinical trial can be found by searching trial registration number ACTRN12623000108617 on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au).

On June 3, 2024 GSK plc (LSE/NYSE: GSK) reported updated, longer-term results from the phase II supported collaborative study with Memorial Sloan Kettering Cancer Center (MSK) evaluating Jemperli (dostarlimab) as a first-line treatment—as an alternative to surgery—for mismatch repair deficient (dMMR) locally advanced rectal cancer (Press release, GlaxoSmithKline, JUN 3, 2024, View Source [SID1234644010]). The trial showed an unprecedented 100% clinical complete response rate (cCR) in 42 patients who completed treatment with dostarlimab, defined as complete pathologic response or no evidence of tumours as assessed by magnetic resonance imaging, endoscopy and digital rectal exam. In the first 24 patients evaluated, a sustained clinical complete response with a median follow-up of 26.3 months (95% CI: 12.4-50.5) was observed.

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These late-breaking data are being presented today at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (31 May – 4 June) in Chicago, IL as a rapid oral presentation (abstract LBA3512). The latest research presented today from the phase II trial builds on the findings initially presented in a late-breaking presentation at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting with simultaneous publication in The New England Journal of Medicine.1

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "The data showing no evidence of disease in 42 patients is remarkable. These results bring us one step closer to understanding the potential of dostarlimab in this curative-intent setting for patients with dMMR locally advanced rectal cancer. We look forward to evaluating dostarlimab in certain colorectal cancers in our ongoing AZUR-1 and AZUR-2 registrational studies."

The current standard-of-care (SoC) for patients with dMMR/microsatellite instability-high (MSI-H) locally advanced rectal cancer is initial treatment with chemotherapy plus radiation followed by surgery to remove the tumour along with portions of the intestine and/or surrounding tissue.1 This results in initial positive outcomes for most patients, but nearly one-third ultimately die from cancer that has spread to other parts of the body (distant metastasis).2 Additionally, the surgery and chemoradiotherapy associated with SoC can lead to long-term adverse effects that have a significantly negative impact on quality of life, including bowel, urinary and sexual dysfunction, secondary cancers and infertility.1

Andrea Cercek, MD, Section Head of Colorectal Cancer and Co-Director of the Center for Young Onset Colorectal and Gastrointestinal Cancer, MSK, and Principal Investigator of the phase II study said: "These findings demonstrate the potential of dostarlimab as a novel approach to treating locally advanced dMMR rectal cancer that leads to durable complete tumour regression without the need for life-altering treatment. As a clinician, I’ve seen firsthand the debilitating impact of standard treatment of dMMR rectal cancer and am thrilled about the potential of dostarlimab in these patients."

The safety and tolerability profile of dostarlimab was generally consistent with the known safety profile of the agent. No adverse events of grade 3 or higher were reported in this trial.

Dostarlimab is not approved anywhere in the world for the frontline treatment of locally advanced dMMR rectal cancer. GSK is advancing studies evaluating dostarlimab in patients with advanced/metastatic stages of dMMR/MSI-H colorectal cancer through its AZUR clinical trial programme. AZUR-1 is a global, multi-centre, open-label, phase II registrational clinical trial investigating the efficacy and safety of dostarlimab as monotherapy – as a replacement for chemotherapy, radiation and/or surgery – for treatment-naïve patients with dMMR/MSI-H locally advanced rectal cancer. The AZUR-1 trial aims to confirm the findings of the supported collaborative study in locally advanced dMMR rectal cancer led by Dr. Cercek at MSK. AZUR-2 is a phase III trial evaluating the efficacy of perioperative dostarlimab compared with SoC in participants with untreated T4N0 or Stage III (resectable) dMMR/MSI-H colon cancer.

About dMMR/MSI-H rectal cancer
Rectal cancer is a form of cancer that starts in the rectum, the final section of the large intestine, and is often categorised as part of a group of cancers called colorectal cancer.3 Colorectal cancer is the third most commonly diagnosed cancer in the world.4 In the US, it is estimated that approximately 46,220 individuals are diagnosed annually with rectal cancer.5 Approximately 5-10% of all rectal cancers are mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H), meaning that they contain abnormalities that affect the proper repair of DNA when copied in a cell.6 Mismatch repair-deficient status is a biomarker that has been shown to predict response to immune checkpoint blockade with PD-1 therapy.7,8 Tumours with this biomarker are most commonly found in endometrial, colorectal and other gastrointestinal cancers but may also be found in other solid tumours.9-12

About Jemperli (dostarlimab)
Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology-based research and development programme. A robust clinical trial programme includes studies of Jemperli alone and in combination with other therapies in gynaecologic, colorectal and lung cancers, as well as where there are opportunities for transformational outcomes. It is the first and only immuno-oncology treatment approved, in combination with chemotherapy, in the frontline setting for primary advanced or recurrent dMMR/MSI-H endometrial cancer.

In the US, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is dMMR, as determined by a US FDA-approved test, or MSI-H, and as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. The sBLA supporting this indication in combination with carboplatin and paclitaxel for dMMR/MSI-H primary advanced or recurrent endometrial cancer received Breakthrough Therapy designation and Priority Review from the US FDA. Jemperli is also indicated in the US for patients with dMMR recurrent or advanced solid tumours, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli, and cobolimab (GSK4069889), a TIM-3 antagonist.

Important Information for Jemperli in the EU
Indication 
Jemperli is indicated:

in combination with carboplatin-paclitaxel, for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy;
as monotherapy for treating adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
Refer to the Jemperli EMA Reference Information for a full list of adverse events and the complete important safety information in the EU here: View Source

On June 3, 2024 Genmab A/S (Nasdaq: GMAB) reported that data from the Phase 2 innovaTV 207 trial (NCT03485209) Part C (n=40), investigating tisotumab vedotin, an antibody-drug conjugate directed to tissue factor, demonstrated encouraging antitumor activity as a monotherapy in patients with head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on or after first-line therapy (Press release, Genmab, JUN 3, 2024, View Source [SID1234644009]). The study showed 32.5% of patients achieved a confirmed objective response rate (cORR), one patient experienced a complete response (CR) and 12 achieved a partial response (PR). These results were presented in a rapid oral session today at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, being held in Chicago, Illinois, May 31 – June 4, 2024.

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In the HNSCC cohort of innovaTV 207 Part C (n=40), median duration of response (DOR) was 5.6 months and median time-to-response (TTR) was 1.4 months. All patients were required to have received a platinum-based regimen in the recurrent or metastatic setting or have persistent disease following platinum-based chemoradiation and a checkpoint inhibitor (CPI), if eligible. The study also showed that among patients with no more than one or two lines of therapy in the recurrent or metastatic setting (n=25), 40% had achieved a cORR at the time of data cut-off.

"Most patients with recurrent or metastatic head and neck squamous cell carcinoma experience disease progression despite the use of platinum-based therapy and immunotherapy, and treatment options are limited," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab, "These updated results underscore the importance of our ongoing work with our partner to advance the clinical development program for tisotumab vedotin and investigate potential treatment options for pretreated patients living with unmet needs."

The safety findings were consistent with previous tisotumab vedotin trials, and no new safety signals were observed. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 67.5% of patients, and the most common were peripheral neuropathy events (40%). Adverse events of special interest (of any grade) were prespecified for ocular, peripheral neuropathy, and bleeding events, and occurred in 52.5%, 47.5%, and 40% patients, respectively.

As of December 2023, 40 patients with recurrent or metastatic HNSCC were treated with tisotumab vedotin monotherapy (1.7 mg/kg intravenously, once every two weeks). In this cohort, 32 (80%) received prior platinum-based therapy, 19 (47.5%) received at least two prior lines of systemic therapy (median: 2; range: 1-3), 40 (100%) received prior CPI, 23 (57.5%) received prior taxane, and 27 (67.5%) received prior cetuximab. The primary sites at diagnosis were oropharynx (n=16), larynx (n=13), and oral cavity (n=9).

About the innovaTV 207 Trial
The innovaTV 207 trial (NCT03485209) is an open-label, global, Phase 2, multicohort, multicenter study evaluating tisotumab vedotin monotherapy or in combination for advanced solid tumors. In Part C, patients with recurrent or metastatic HNSCC received tisotumab vedotin monotherapy (1.7 mg/kg IV once every two weeks). All patients were required to have received a platinum-based regimen, either in the recurrent/metastatic setting, or to have persistent disease following platinum-based chemoradiation and a checkpoint inhibitor, if eligible. The primary endpoint of the trial is confirmed objective response rate (cORR) per RECIST 1.1 per investigator, defined as the proportion of patients who achieve a confirmed complete or partial response. Selected secondary endpoints include duration of response (DOR), time-to-response (TTR), and safety. For more information about the phase 2 innovaTV 207 clinical trial of tisotumab vedotin, please visit www.clinicaltrials.gov.

About Tisotumab Vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin-tftv is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin-tftv also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

Tisotumab vedotin (TIVDAK) has received full approval by the U.S. FDA for the treatment of adult patients with recurrent or metastatic cervical cancer (r/mCC) with disease progression on or after chemotherapy. Tisotumab vedotin in HNSCC is not approved in any country, including the U.S. and the EU. The safety and efficacy of tisotumab vedotin has not been established for these investigational uses.

Virtual mid- to late-stage pipeline update at ASCO (Free ASCO Whitepaper) 2024
On Monday, June 3, at 9:00 AM CDT (10:00 AM EDT/4:00 PM CEST), Genmab will host a review of data presented at ASCO (Free ASCO Whitepaper) from its mid- to late-stage pipeline. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com. This meeting is not an official program of the ASCO (Free ASCO Whitepaper) Annual Meeting.