On May 26, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported clinical results from its C-144-01 clinical study in patients with advanced (unresectable or metastatic) melanoma who progressed on prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also on prior BRAF or BRAF/MEK inhibitor therapy (Press release, Iovance Biotherapeutics, MAY 26, 2022, View Source [SID1234615089]).

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In registrational Cohort 4 (n=87), the objective response rate (ORR) by an independent review committee (IRC) using RECIST 1.1 criteria was 29% (95% confidence interval (CI): 19.5%, 39.4%) with three complete responses and 22 partial responses. The median duration of response (DOR) in Cohort 4 by IRC was 10.4 months with a median study follow-up of 23.5 months. These data demonstrate that one-time treatment with lifileucel therapy may provide meaningful benefit in heavily pre-treated patients. Cohort 4’s findings are supported by Cohort 2 (n=66), where the ORR by IRC was 35% (95% CI: 23.5%, 47.6%) with five complete responses and 18 partial responses. The median DOR in Cohort 2 was not reached with a median study follow-up of 36.6 months. The ORR by IRC for pooled patients (n=153) from both Cohorts 2 and 4 was 31% (95% CI: 24.1%, 39.4%) and median DOR was not reached at a median study follow up of 27.6 months.

Patients in Cohort 4 exhibited higher baseline disease burden in comparison to patients in Cohort 2, including a substantially higher proportion of patients with elevated baseline lactate dehydrogenase (LDH) levels, a well-known negative prognostic factor (64.4% versus 40.9%), as well as a greater number of tumor lesions at baseline (83.9% versus 65.2% with more than three lesions). In addition, patients in Cohort 2 also had approximately half the cumulative duration of anti-PD-1 therapy before lifileucel therapy in comparison to patients in Cohort 4. Reduced duration of prior anti-PD-1 therapy was shown1 to be associated with an increase of DOR to lifileucel. The treatment-emergent adverse event profile in both cohorts was consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and interleukin-2 (IL-2) and was also consistent between Cohorts 2 and 4.

Iovance plans to present additional data from Cohorts 2 and 4 at a medical meeting in the second half of 2022. The planned BLA submission for lifileucel in advanced melanoma using these data remains on track for August 2022.

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "We are pleased to report positive results for lifileucel from the registrational Cohort 4 data from the C-144-01 study. Iovance is proceeding towards submission of a BLA in August 2022 using these results as well as the potentially supportive results from Cohort 2 of the C-144-01 study. We thank our patients, their families, and our investigators, employees, shareholders, and advocates for their support. We look forward to reporting further progress with our lifileucel BLA and launch preparations in 2022."

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, commented, "Treatment of melanoma patients after failure of anti-PD-1 therapy remains a critical unmet medical need without an approved therapeutic option. Available care for metastatic melanoma patients in this setting is chemotherapy, which has been reported to offer a four to ten percent response rate with a very short median duration of response. We are excited about the results from registrational Cohort 4 of the C-144-01 study and the potential of lifileucel as a new treatment option for these patients."

Webcast and Conference Call

Iovance will host a conference call today at 5:00 p.m. ET to discuss the updates for the C-144-01 clinical study. The conference call dial-in numbers are 1 (844) 646-4465 (domestic) or 1 (615) 247-0257 (international) and the conference ID is #5945054. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.

1Larkin, J.M.G., et al., Lifileucel (LN-144), a Cryopreserved Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients with Advanced Melanoma: Evaluation of Impact of Prior Anti–PD-1 Therapy, ASCO (Free ASCO Whitepaper) Annual Meeting, June 6, 2021. Presentation.

On May 26, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported additional efficacy data from the pivotal SORAYA study evaluating mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab) and an integrated safety summary of single-agent mirvetuximab across multiple studies in patients with FRα-positive recurrent ovarian cancer (Press release, ImmunoGen, MAY 26, 2022, View Source [SID1234615088]). These findings will be highlighted in two posters at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 3-7, 2022. The data from SORAYA have been selected for the Best of ASCO (Free ASCO Whitepaper) Program.

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"Treatment options remain limited for patients with platinum-resistant ovarian cancer, particularly for those who have received prior bevacizumab, and are associated with low response rates, short durations of response, and considerable toxicities," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "We believe these data further reinforce mirvetuximab’s potential to become a new standard of care in this population. With our biologics license application accepted and filed by FDA with Priority Review, we look forward to bringing mirvetuximab to patients with the most urgent need later this year."

CHARACTERIZATION OF ANTI-TUMOR ACTIVITY IN THE SORAYA STUDY
SORAYA enrolled 106 platinum-resistant ovarian cancer patients with high FRα expression who have been previously treated with 1 to 3 prior systemic treatments, at least one of which included bevacizumab. The primary endpoint was confirmed objective response rate (ORR) as assessed by investigator. Secondary endpoints included duration of response (DOR) as assessed by investigator, CA-125 response, safety and tolerability, progression-free survival (PFS), overall survival (OS); ORR, DOR, and PFS by blinded independent central review were sensitivity analyses. Data from SORAYA were first presented at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting; the updated analyses to be presented at ASCO (Free ASCO Whitepaper) are based on the 120-day cut-off date of April 29, 2022.

ORR by investigator was 32.4% (95% confidence interval [CI]: 23.6%, 42.2%), including 5 complete responses. Median time to response was 1.5 months (range 1.0 to 5.6) and 71.4% of patients demonstrated tumor reduction.
The disease control rate (DCR), defined as complete response (CR), partial response, or stable disease maintained for ≥12 weeks, was 51.4%.
The median DOR was 6.9 months (95% CI: 5.6, 9.7) by investigator, with 5 responders continuing on mirvetuximab as of April 29, 2022.
The median PFS assessed by investigator was 4.3 months (95% CI: 3.7, 5.2).
The preliminary median OS was 13.8 months, with 54% of the evaluable patient population event-free.
In the sensitivity analyses by blinded independent central review, outcomes were similar: ORR 30.2% (95% CI: 21.3%, 40.4%) with 6 CRs; mDOR not reached (95% CI: 5.0, NR); mPFS 5.5 months (95% CI: 3.8, 6.9).
In responders, depth and duration of response did not appear to be affected by dose reductions.
Mirvetuximab was well-tolerated, consistent with previous studies. The most common treatment-related adverse events (TRAE) included blurred vision (41% all grade, 6% grade 3+), keratopathy (29% all grade, 9% grade 3+), and nausea (29% all grade, 0% grade 3+).
TRAEs generally resolved with supportive care or, if needed, dose modifications; the discontinuation rate due to TRAEs was 9%.
Kaplan-Meier plots for PFS and OS to be included in poster.
"I believe these additional analyses from SORAYA further support mirvetuximab’s potential to become the first biomarker-directed agent indicated for patients with platinum-resistant ovarian cancer," said Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator. "The tumor reduction observed in over 70% of patients, along with the PFS curve and the preliminary median overall survival of 13.8 months, are impressive. If approved, I look forward to being able to offer mirvetuximab to my patients and continuing to support its further development in patients with ovarian cancer."

INTEGRATED SAFETY SUMMARY OF SINGLE-AGENT MIRVETUXIMAB SORAVTANSINE
This retrospective pooled analysis included 464 patients with FRα-positive, recurrent ovarian cancer across three studies: a Phase 1 first-in-human trial, the Phase 3 FORWARD I trial, and the pivotal Phase 3 SORAYA trial.

Mirvetuximab monotherapy has a differentiated safety profile consisting primarily of low-grade gastrointestinal and ocular events; adverse events generally resolved and were managed with supportive care and, if needed, dose modifications. The discontinuation rate due to TRAEs was 7%.
The most common TRAEs included blurred vision (42% all grade, 3% grade 3+), nausea (40% all grade, 2% grade 3+), diarrhea (33% all grade, 2% grade 3+), fatigue (31% all grade, 2% grade 3+), keratopathy (26% all grade, 3% grade 3+), and dry eye (22% all grade, 1% grade 3+).
Mirvetuximab monotherapy did not result in any corneal ulcers or perforations, and no patients had permanent ocular sequelae.
The majority of patients with ocular events did not require dose delay or dose reduction; <1% of patients discontinued mirvetuximab due to an ocular event.
"Having personally treated over 100 patients with mirvetuximab, I have helped my colleagues better understand how to manage the associated ocular events," said Kathleen Moore, Director of the Oklahoma TSET Phase I Program, Professor of the Section of Gynecologic Oncology at The University of Oklahoma College of Medicine, and MIRASOL Principal Investigator. "With prevention and mitigation strategies in place, patients presenting with ocular events have been able to complete their treatment, maintain their responses, and had no permanent sequelae from these events. These data demonstrate mirvetuximab’s differentiated safety profile and I look forward to the potential approval and launch later this year."

POSTER SESSION DETAILS
The following posters will be available on Saturday, June 4 in the ASCO (Free ASCO Whitepaper) Meeting Library:

Additional information can be found at www.asco.org.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.

On May 26, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that complete HB-200 Phase 1 results (NCT04180215) for single-vector HB-201 and alternating 2-vector HB-202/HB-201 in patients with advanced Human Papillomavirus 16-positive (HPV16+) cancers, including the recommended Phase 2 dose for HB-202/HB-201, will be shared in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 (Press release, Hookipa Biotech, MAY 26, 2022, https://ir.hookipapharma.com/news-releases/news-release-details/hookipa-present-complete-hb-200-phase-1-results-and-recommended [SID1234615087]). Data as of March 31, 2022 will be presented on 68 patients, 54 of whom had head and neck squamous cell carcinoma (HNSCC).

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"We look forward to sharing the full Phase 1 data results on our HB-200 program at ASCO (Free ASCO Whitepaper). The final analysis shows that HB-201 and 2-vector HB-202/HB-201 were generally well tolerated and showed anti-tumor activity in these difficult-to-treat patients. We also will share additional translational data that continue to show robust tumor-specific T cell responses from use of our HB-200 therapies," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We are continuing to advance this truly novel science through the clinic, and the learnings from this phase help deepen our understanding of the potential of our technology. These insights inform our path as we advance the 2-vector HB-202/HB-201 immunotherapy into the ongoing Phase 2 HNSCC portion of the study, as well as our approach to our HB-300 program in prostate cancer."

The abstract is available on the ASCO (Free ASCO Whitepaper) website with key details noted below:

Recommended Phase 2 dose (RP2D) of HB-200 arenavirus-based cancer immunotherapies in patients with HPV16+ cancers

Abstract # 2517, Developmental Therapeutics – Immunotherapy

Poster session: Sunday, June 5, 8:00 a.m. – 11:00 a.m. CDT
Poster discussion session: Sunday, June 5, 11:30 a.m. – 1:00 p.m. CDT in Hall D2
Presenter: Siqing Fu, M.D., Ph.D., Professor of Investigational Cancer Therapeutics and principal investigator at The University of Texas MD Anderson Cancer Center
Key findings:

Single-vector HB-201 and 2-vector HB-202/HB-201 immunotherapies were generally well tolerated and showed anti-tumor activity in heavily pre-treated patients with HPV16+ head and neck cancer

HB-201 was evaluated at three dose levels, with two dosing schedules and two administration routes for safety, efficacy and immunogenicity

HB-202/HB-201 was evaluated at four dose levels and two administration routes for safety, efficacy, and the recommended Phase 2 dose

Anti-tumor activity in this heavily pre-treated patient population was observed with HB-201 and HB-202/HB-201 treatments alone, including sustained tumor control and partial responses.
About HB-202/HB-201
HB-201 and HB-202/HB-201 are HOOKIPA’s lead oncology candidates engineered with the company’s proprietary replicating arenaviral vector platform. HB-201 is a single-vector compound that uses Lymphocytic Choriomeningitis Virus as its arenaviral backbone. HB-202 is a single-vector compound that uses Pichinde Virus as its arenaviral backbone. Both express the same antigen, an E7E6 fusion protein derived from HPV16. HB-202/HB-201 is an alternating 2-vector immunotherapy designed to further focus the immune response against the target antigen. In pre-clinical studies, alternating administration of HB-201 and HB-202 resulted in a ten-fold increase in immune response and better disease control than either compound alone. Both novel immunotherapy candidates, in combination with pembrolizumab, received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of 1st-line advanced/metastatic HPV16+ head and neck cancers.

About the HB-200 trial (NCT04180215)
This Phase 1/2 clinical trial is an open-label trial exploring different dose levels and dosing schedules in individuals with treatment-refractory HPV16+ head and neck cancers who progressed on standard of care, including checkpoint inhibitors. The HB-200 trial is evaluating two HOOKIPA compounds: HB-201 as single-vector therapy, HB-202/HB-201 as an alternating 2-vector therapy, and both in combination with a PD-1 inhibitor. The primary endpoint of Phase 1 is a recommended Phase 2 dose. Secondary endpoints include safety and tolerability, as well as preliminary efficacy defined by RECIST 1.1. The trial also includes exploratory objectives on T cell response and pharmacodynamic biomarkers.

The Phase 2 part of the trial is open-label with a primary endpoint of preliminary anti-tumor activity, defined by RECIST 1.1, for objective response rate and disease control rate. Secondary endpoints including safety, overall survival, progression-free survival and duration of response. Phase 2 is ongoing, evaluating HB-201 in combination with pembrolizumab in 1st– and 2nd-line plus settings, with additional arms planned based on final Phase 1 results.

About Human Papillomavirus-driven Cancers
Human Papillomavirus, or HPV, is a common viral infection estimated to cause about 5 percent of the worldwide cancer burden. This includes up to 60 percent of head and neck, 89 percent of cervical, 78 percent of vaginal, 88 percent of anal, 67 percent of vulvar and 50 percent of penile cancers.

While there are numerous HPV types associated with cancer, HPV16 is the most common cause of cancer. Most HPV infections are cleared from the body with no lasting consequences. However, in some cases, HPV DNA becomes integrated into chromosomal DNA. When host cells take up this DNA, they express the HPV E6 and E7 proteins. This uptake can potentially lead to cancer since expression of these proteins leads to alterations in cell cycle control, which in turn predisposes these cells to become cancerous.

On May 26, 2022 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported that company management will participate in a fireside chat at the 2022 Jefferies Global Healthcare Conference on Wednesday, June 8, 2022 at 8:30 am ET (Press release, Heron Therapeutics, MAY 26, 2022, View Source [SID1234615086]). The conference is taking place June 8-10th, 2022 in New York, NY.

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A live webcast of the fireside chat will be available on the Company’s website at www.herontx.com in the Investor Resources section.

On MAY 26, 2022 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating several investigational medicines in the company’s pipeline, or created using Genmab’s innovative drug development platforms, will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held at McCormick Place, in Chicago, IL, and virtually, June 3-7 (Press release, Genmab, MAY 26, 2022, View Source [SID1234615085]). The presentations will include data from multiple arms of the phase 1b/2 EPCORE NHL-2 clinical trial, evaluating the safety and preliminary efficacy of epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, in combination with standard-of-care therapies for the treatment of various types of B-cell non-Hodgkin lymphoma (NHL), including first-line, high-risk diffuse large B-cell lymphoma (DLBCL), relapsed or refractory DLBCL, and relapsed or refractory follicular lymphoma (FL). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV).

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In addition, several abstracts evaluating tisotumab vedotin (TIVDAK) in various tumor types will be presented, including an oral presentation of the innovaTV 205 study evaluating tisotumab vedotin in combination with carboplatin or pembrolizumab in first-line patients with recurrent or metastatic cervical cancer (r/mCC). Tisotumab vedotin is being co-developed by Genmab and Seagen (Nasdaq: SGEN), under an agreement in which the companies share costs and profits for the product on a 50:50 basis.

Results from several clinical trials evaluating Janssen Biotech, Inc. (Janssen’s) subcutaneous formulation of daratumumab, and Janssen’s bispecific programs leveraging Genmab’s DuoBody technology platform, will be presented. Daratumumab is being developed by Janssen under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab, and the companies have a research and license agreement to create and develop bispecific antibodies using Genmab’s DuoBody technology platform.

All abstracts accepted for presentation have been published on the ASCO (Free ASCO Whitepaper) website.

"This year’s ASCO (Free ASCO Whitepaper) provides a great opportunity for Genmab to share data evaluating epcoritamab, our first-in-class approved medicine tisotumab vedotin, and our innovative technologies, which reinforce our commitment to delivering new therapeutic options to patients in need," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Through our own research and development, and through industry partnerships, Genmab is developing differentiated therapies with the goal of transforming the future of cancer treatment."

Abstracts accepted for presentation at ASCO (Free ASCO Whitepaper) include:

Epcoritamab (DuoBody-CD3xCD20):

Abstract #: 7523. First-line treatment with subcutaneous (SC) epcoritamab (epco) + R-CHOP in patients (pts) with high-risk diffuse large B-cell lymphoma (DLBCL): phase 1/2 data update; Falchi et al. Saturday, June 4, 2022, 8:00-11:00 a.m. CDT/9:00 p.m.-12:00 p.m. EDT.
Abstract #: 7524. Subcutaneous epcoritamab with rituximab + lenalidomide (R2) in patients (pts) with relapsed or refractory (R/R) follicular lymphoma (FL): update from phase 1/2 trial; Falchi et al. Saturday, June 4, 2022, 8:00-11:00 a.m. CDT/9:00 p.m.-12:00 p.m. EDT.
Abstract #: 7528. Subcutaneous epcoritamab + R-DHAX/C in patients (pts) with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) eligible for autologous stem cell transplant (ASCT): preliminary phase 1/2 results; Abrisqueta et al. Saturday, June 4, 2022, 8:00-11:00 a.m. CDT/9:00 p.m.-12:00 p.m. EDT.
Abstract #: 7527. Epcoritamab (epco) with gemcitabine + oxaliplatin (GemOx) in patients (pts) with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) ineligible for autologous stem cell transplant (ASCT) induces high response rate even in pts failing CAR T therapy; Brody et al. Saturday, June 4, 2022, 8:00-11:00 a.m. CDT/9:00 p.m.-12:00 p.m. EDT.
Abstract #: 7576. DLBCL Cell of Origin Typing and Whole Transcriptome Analysis using Single Slides with HTG EdgeSeq; Loya, et al. Saturday, June 4, 2022, 8:00-11:00 a.m. CDT/9:00 p.m.-12:00 p.m. EDT.
Tisotumab Vedotin:

Abstract #: 5507. Tisotumab vedotin (TV) + pembrolizumab (pembro) in first-line (1L) recurrent or metastatic cervical cancer (r/mCC): Interim results of ENGOT Cx8/GOG 3024/innovaTV 205; D. Lorusso et al. Monday, June 6, 2022, 8:00-11:00 a.m. CDT/9:00 a.m.-12:00 p.m. EDT.
Abstract#: TPS5603. Trial in progress update on ENGOT-cx8/GOG-3024/innovaTV 205: Addition of a new cohort of tisotumab vedotin (TV) + pembrolizumab (pembro) + carboplatin (carbo) ± bevacizumab (bev) in first line (1L) recurrent/metastatic cervical cancer (r/mCC); I. Vergote et al. Saturday, June 4, 2022, 1:15-4:15 p.m. CDT/2:15-5:15 p.m. EDT.
Abstract #: TPS6100. innovaTV 207: New combination dosing cohorts in the open label phase 2 study of tisotumab vedotin in solid tumors; X. Le et al. Monday, June 6, 2022, 1:15-4:15 p.m. CDT/2:15 p.m.-5:15 p.m. EDT.
Abstract #: 5532. Factors Associated with Receipt of Second-Line Recurrent or Metastatic Cervical Cancer Treatment in the US: A Retrospective Administrative Claims Analysis; K. Sonawane et al. Saturday, June 4, 2022, 1:15-4:15 p.m. CDT/2:15-5:15 p.m. EDT.
Abstract #: 5523. Cervical Cancer Geographical Burden Analyzer: An Interactive, Open-Access Tool For Understanding Geographical Disease Burden in Recurrent or Metastatic Cervical Cancer Patients; T. Castellano et al. Saturday, June 4, 2022, 1:15-4:15 p.m. CDT/2:15-5:15 p.m. EDT
Abstract #: E17520. Productivity losses under various second-line recurrent or metastatic cervical cancer treatment scenarios in the US; T. Ayer et al.
Abstract #: E17525. Patterns of Care in Medicaid-Enrollees with recurrent or metastatic Cervical Cancer; C. A. Leath et al.
Daratumumab:

Subcutaneous daratumumab (DARA SC) versus active monitoring in patients (pts) with high-risk smoldering multiple myeloma (SMM): randomized, open-label, phase 3 AQUILA study; Dimopoulos et al.
Time to response, duration of response, and patient-reported outcomes (PROs) with daratumumab (DARA) plus lenalidomide and dexamethasone (D-Rd) vs lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of the phase 3 MAIA study; Facon et al.
Efficacy and safety of daratumumab (DARA) in pediatric and young adult patients (pts) with relapsed/refractory T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL): results from the phase 2 DELPHINUS study; Hogan et al.
Daratumumab (DARA) + lenalidomide, bortezomib, and dexamethasone (RVd) in Black patients (pts) with transplant-eligible newly diagnosed multiple myeloma (NDMM): an updated subgroup analysis of GRIFFIN; Nooka et al.
Daratumumab (DARA) + lenalidomide, bortezomib, and dexamethasone (RVd) in transplant-eligible newly diagnosed multiple myeloma (NDMM): a post hoc analysis of sustained minimal residual disease (MRD) negativity from GRIFFIN; Rodriguez et al.
Daratumumab (DARA) in combination with bortezomib plus dexamethasone (D-Vd) or lenalidomide plus dexamethasone (D-Rd) in relapsed or refractory multiple myeloma (RRMM): subgroup analysis of the phase 3 CASTOR and POLLUX studies in patients (pts) with early or late relapse after initial therapy; Spencer et al.
About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.i Epcoritamab was developed with selective, silencing mutations that may limit systemic, non-specific activity.ii CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.iii,iv Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

About Tisotumab Vedotin
Tisotumab vedotin-tftv (TIVDAK) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Seagen’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 suggests that the anticancer activity of tisotumab vedotin 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 also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

In September 2021, the U.S. Food and Drug Administration granted accelerated approval for tisotumab vedotin-tftv (TIVDAK) in adult patients with previously treated recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, making it the first and only approved ADC for these patients. The ongoing clinical trial InnovaTV 301, an open label, randomized, global trial, is intended as the confirmatory trial for use in verifying and describing the clinical benefit and as support for US and global regulatory applications.

TIVDAK (tisotumab vedotin-tftv) U.S Indication & Important Safety Information
TIVDAK is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information

BOXED WARNING: OCULAR TOXICITY
TIVDAK caused changes in the corneal epithelium and conjunctiva resulting in changes in vision, including severe vision loss, and corneal ulceration. Conduct an ophthalmic exam at baseline, prior to each dose, and as clinically indicated. Adhere to premedication and required eye care before, during, and after infusion. Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity.

Warnings and Precautions
Ocular Adverse Reactions occurred in 60% of patients with cervical cancer treated with TIVDAK across clinical trials. The most common were conjunctival adverse reactions (40%), dry eye (29%), corneal adverse reactions (21%), and blepharitis (8%). Grade 3 ocular adverse reactions occurred in 3.8 % of patients, including severe ulcerative keratitis in 3.2% of patients. One patient experienced ulcerative keratitis with perforation requiring corneal transplantation. Cases of symblepharon were reported in patients with other tumor types treated with TIVDAK at the recommended dose. In innovaTV 204, 4% of patients experienced visual acuity changes to 20/50 or worse including 1% of patients who experienced a visual acuity change to 20/200. Of the patients who experienced decreased visual acuity to 20/50 or worse, 75% resolved, including the patient who experienced decreased visual acuity to 20/200.

Refer patients to an eye care provider for an ophthalmic exam including visual acuity and slit lamp exam at baseline, prior to each dose, and as clinically indicated. Adhere to premedication and required eye care to reduce the risk of ocular adverse reactions. Promptly refer patients to an eye care provider for any new or worsening ocular signs and symptoms. Withhold dose, reduce the dose, or permanently discontinue TIVDAK based on the severity of the adverse reaction.

Peripheral Neuropathy (PN) occurred in 42% of cervical cancer patients treated with TIVDAK across clinical trials; 8% of patients experienced Grade 3 PN. PN adverse reactions included peripheral neuropathy (20%), peripheral sensory neuropathy (11%), peripheral sensorimotor neuropathy (5%), motor neuropathy (3%), muscular weakness (3%), and demyelinating peripheral polyneuropathy (1%). One patient with another tumor type treated with TIVDAK at the recommended dose developed Guillain- Barre syndrome. Monitor patients for signs and symptoms of neuropathy. For new or worsening PN, withhold, dose reduce, or permanently discontinue TIVDAK based on the severity of PN.

Hemorrhage occurred in 62% of cervical cancer patients treated with TIVDAK across clinical trials. The most common all grade hemorrhage adverse reactions were epistaxis (44%), hematuria (10%), and vaginal hemorrhage (10%). Grade 3 hemorrhage occurred in 5% of patients. Monitor patients for signs and symptoms of hemorrhage. For patients experiencing pulmonary or CNS hemorrhage, permanently discontinue TIVDAK. For Grade ≥2 hemorrhage in any other location, withhold until bleeding has resolved, blood hemoglobin is stable, there is no bleeding diathesis that could increase the risk of continuing therapy, and there is no anatomical or pathologic condition that can increase the risk of hemorrhage recurrence. After resolution, either resume treatment or permanently discontinue TIVDAK.

Pneumonitis: Severe, life-threatening, or fatal pneumonitis can occur in patients treated with antibody-drug conjugates containing vedotin, including TIVDAK. Among patients with cervical cancer treated with TIVDAK across clinical trials, 2 patients (1.3%) experienced pneumonitis, including 1 patient who had a fatal outcome.

Monitor patients for pulmonary symptoms of pneumonitis. Infectious, neoplastic, and other causes for symptoms should be excluded through appropriate investigations.

Withhold TIVDAK for patients who develop persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue TIVDAK in all patients with Grade 3 or 4 pneumonitis.

Embryo-Fetal Toxicity: TIVDAK can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TIVDAK and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TIVDAK and for 4 months after the last dose.

Adverse Reactions
In the innovaTV 204 clinical trial (n=101), serious adverse reactions occurred in 43% of patients; the most common (≥3%) were ileus (6%), hemorrhage (5%), pneumonia (4%), PN, sepsis, constipation, and pyrexia (each 3%). Fatal adverse reactions occurred in 4% of patients who received TIVDAK, including septic shock, pneumonitis, sudden death, and multisystem organ failure (each 1%).

Adverse reactions leading to permanent discontinuation occurred in 13% of patients receiving TIVDAK; the most common (≥3%) were PN (5%) and corneal adverse reactions (4%). Adverse reactions leading to dose interruption occurred in 47% of patients; the most common (≥3%) were PN (8%), conjunctival adverse reactions (4%), and hemorrhage (4%). Adverse reactions leading to dose reduction occurred in 23% of patients; the most common (≥3%) were conjunctival adverse reactions (9%) and corneal adverse reactions (8%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (52%), fatigue (50%), lymphocytes decreased (42%), nausea (41%), PN (39%), alopecia (39%), epistaxis (39%), conjunctival adverse reactions (37%), hemorrhage (32%), leukocytes decreased (30%), creatinine increased (29%), dry eye (29%), prothrombin international normalized ratio increased (26%), activated partial thromboplastin time prolonged (26%), diarrhea (25%), and rash (25%).

Drug interactions

Strong CYP3A4 Inhibitors: Concomitant use with strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E (MMAE) exposure, which may increase the risk of TIVDAK adverse reactions. Closely monitor patients for TIVDAK adverse reactions.

Use in Specific Populations

Moderate or Severe Hepatic Impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Lactation: Advise lactating women not to breastfeed during TIVDAK treatment and for at least 3 weeks after the last dose.

Please see full prescribing information, including BOXED WARNING for TIVDAK here.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat certain multiple myeloma indications. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of certain multiple myeloma indications and the first and only approved treatment for certain patients with light-chain (AL) amyloidosis.v,vi,vii

Please see local country prescribing information for all labeled indication and safety information.