On May 26, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of research across various types of cancer from its oncology portfolio during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (#ASCO22), which is taking place virtually and in-person in Chicago from June 3 to 7 (Press release, Eisai, MAY 26, 2022, View Source [SID1234615166]). Notable presentations include a poster discussion of safety and efficacy data (NCT03386942(New Window); Abstract: #5513) from the platinum-resistant ovarian cancer cohort expansion of a Phase 1 study evaluating the antibody drug conjugate (ADC) co-developed by Eisai and Bristol Myers Squibb (Headquarters: the United States), farletuzumab ecteribulin (MORAb-202), as well as a poster presentation featuring dose optimization findings for farletuzumab ecteribulin (NCT03386942(New Window); Abstract: #3090).

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"Safety and efficacy analyses in platinum-resistant ovarian cancer for farletuzumab ecteribulin suggest antibody drug conjugates may represent a promising therapeutic strategy for these patients with limited treatment options," said Dr. Takashi Owa, President, Oncology Business Group at Eisai. "Eisai’s first antibody drug conjugate combines our in-house developed anti-folate receptor alpha antibody and our anticancer agent eribulin using an enzyme cleavable linker, illustrating our dedication to building on our medicines to improve cancer care for more patients."

New research from the LEAP (LEnvatinib And Pembrolizumab) clinical program evaluating lenvatinib (LENVIMA) plus pembrolizumab (KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, includes subgroup analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma (RCC) and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanced endometrial carcinoma (EC). A poster discussion will evaluate the impact of subsequent therapies in patients with advanced RCC receiving the combination (NCT02811861(New Window); Abstract: #4514); while a poster presentation will discuss the efficacy of next line therapy after treatment with lenvatinib plus pembrolizumab in advanced EC (NCT03517449(New Window); Abstract: #5587).

"The combination of lenvatinib plus pembrolizumab has helped to expand physicians’ arsenal of treatment options for patients living with advanced renal cell carcinoma and advanced endometrial carcinoma around the world," said Richard C. Woodman, MD, Chief Clinical Officer, Oncology Business Group at Eisai. "Our data at ASCO (Free ASCO Whitepaper) 2022 demonstrate our commitment to continuing to investigate the combination through post-hoc analyses with the goal of providing healthcare professionals with tools to support them in making better-informed treatment decisions for their patients."

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with pembrolizumab. To date, more than 20 trials have been initiated under the LEAP clinical program, which is evaluating the combination across more than 10 different tumor types.

In June 2021, Eisai and Bristol Myers Squibb entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of farletuzumab ecteribulin, a folate receptor alpha (FRα)-targeting ADC. Eisai and Bristol Myers Squibb are currently investigating farletuzumab ecteribulin in FRα-positive solid tumors (inclusive of endometrial, ovarian, lung and breast cancers) in two studies: a Phase 1 clinical study in Japan and a Phase 1/2 clinical study in the United States.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. The majority of abstracts have been made available on Thursday, May 26, 2022, at 5:00 PM EDT and will be available on demand via ASCO (Free ASCO Whitepaper)’s website.

　

Cancer Type Study/Compound Abstract Title Abstract Type & Details
Pipeline
Gynecologic Cancer Farletuzumab Ecteribulin Safety and Efficacy of MORAb-202 in Patients (pts) With Platinum-Resistant Ovarian Cancer (PROC): Results From the Expansion Part of a Phase 1 Trial.
Poster Discussion
Abstract #5513
June 4, 2022
5:30 PM EDT

Shin Nishio, MD, PhD
Kurume University School of Medicine

Farletuzumab Ecteribulin Dose Optimization for MORAb-202, an Antibody-Drug Conjugate (ADC) Highly Selective for Folate Receptor-Alpha (FRα), Using Population Pharmacokinetic (PPK) and Exposure-Response (E-R) Efficacy and Safety Analyses.
Poster Presentation
Abstract #3090
June 5, 2022
9:00 AM EDT

Seiichi Hayato
Eisai
Lenvatinib Combinations

(Plus Pembrolizumab, Pembrolizumab and Chemotherapy or Pembrolizumab and Belzutifan)

Genitourinary Cancer CLEAR (Study 307)/ KEYNOTE-581 Impact of subsequent therapies in patients (pts) with advanced renal cell carcinoma (aRCC) receiving lenvatinib plus pembrolizumab (LEN + PEMBRO) or sunitinib (SUN) in the CLEAR study
Poster Discussion
Abstract #4514
June 4, 2022
5:42 PM EDT

Martin H. Voss, MD
Memorial Sloan Kettering Cancer Center
Gynecologic Cancer Study 309/ KEYNOTE-775 Efficacy of next line of therapy after treatment with lenvatinib (LEN) in combination with pembrolizumab (pembro) versus treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): exploratory analysis of Study 309/KEYNOTE-775
Poster Presentation
Abstract #5587
June 4, 2022
2:15 PM EDT

Vicky Makker, MD
Memorial Sloan Kettering Cancer Center
Gastrointestinal Cancers LEAP-014 First-line lenvatinib plus pembrolizumab plus chemotherapy in esophageal squamous cell carcinoma: LEAP-014 trial in progress
Poster Presentation
Abstract #TPS4167
June 4, 2022
9:00 AM EDT

Jong-Mu Sun, MD
Samsung Medical Center, Sungkyunkwan University School of Medicine
MK-6482-016 Phase 2 Open-label Study of Pembrolizumab Plus Lenvatinib and Belzutifan in Patients With Advanced Solid Tumors
Poster Presentation
Abstract #TPS4173
June 4, 2022
9:00 AM EDT

Robin K. Kelley, MD
University of California San Francisco
Lenvatinib
Gastrointestinal Cancer REFLECT Characterization of tumor responses in patients (pts) with unresectable hepatocellular carcinoma (uHCC) treated with lenvatinib in REFLECT
Poster Presentation
Abstract #4078
June 4, 2022
9:00 AM EDT

Masatoshi Kudo, MD
Kindai University Faculty of Medicine
Additional Research
Gynecologic Cancer ECHO EU Treatment Pattern Treatment patterns and outcomes among patients with recurrent or advanced endometrial cancer in Europe: Endometrial Cancer Health Outcomes Europe (ECHO EU) Study
Online Publication
Abstract #e17627
May 26, 2022
5:00 PM EDT

Vimalanand S Prabhu, PhD
Merck & Co., Inc., Rahway, NJ, USA
Genitourinary Cancer Translational Research Exploratory analysis on crosstalk between intra-tumor immunity and FGF/FGFR pathway in clear cell renal cell carcinoma
Online Publication
Abstract #e16525
May 26, 2022
5:00 PM EDT

Takafumi Narisawa, MD
Yamagata University Faculty of Medicine

On May 26, 2022 Race Oncology Limited ("Race") reported the dose escalation Phase 1b stage of the relapsed or refractory Acute Myeloid Leukaemia (R/R AML) trial running at the Chaim Sheba Medical Centre, Israel has successfully completed after the treatment of the first six patients (Press release, Race Oncology, MAY 26, 2022, View Source [SID1234615165]).

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The six patients were heavily pre-treated and had received a median of four prior lines of AML treatment (range 2-8).

By design, the primary endpoint of the initial phase of this 2-stage clinical trial is establishing the recommended dose to be used in the subsequent Phase 2 expansion (efficacy) stage. This first stage requires identifying the treatment dose level that achieves two or fewer dose-limiting toxicities (DLTs) from six consecutively treated patients. In the initial six patients treated, two DLTs were reported (one Grade 3 elevated liver enzymes and one Grade 5 infection). Both DLTs occurred in the most heavily pre-treated patients who had received five and eight prior lines of treatment, respectively.

"The positive results from the first stage of this trial in such a heavily pre-treated relapsed or refractory Acute Myeloid Leukaemia population is encouraging, especially with three of the patients being subsequently bridged to transplant. We look forward to the next stage of this study which, together with data from the EMD AML Trial (RAC-006) which is soon to commence recruitment in Australia, is extending our understanding of Zantrene in a modern AML setting."

Race CMO Dr David Fuller
Efficacy results in this refractory patient population were very encouraging, with one patient showing a complete response (CR) based on morphology, two patients having a partial response (PR) including one with extramedullary disease, two showing no response (NR), and one patient not assessable (NA) due to death from infection. Infection is a known side effect of all intensive chemotherapeutic regimens and is one of the leading causes of death in AML patients.

"The encouraging results of our Phase I study with Zantrene monotherapy and moreover the current Phase II study altogether with Zantrene in combination in extremely heavily treated advanced high risk AML patients are encouraging and may indicate a role for Zantrene in modern AML treatment paradigm to the benefit of our patients."

Study Lead Prof Arnon Nagler
Three patients (1 CR and 2 PR) were bridged to an allogeneic stem cell transplant. Bridging a patient to transplant is an important positive outcome in AML treatment as it offers the patient the potential of long-term remission. Of note, these three patients had all received less than five prior lines of treatment. Poor or no response to known efficacious treatments is common and expected in heavily pre-treated cancer patients.

"We are very excited about the positive data from the first stage of this trial in such a heavily pre-treated R/R AML population, and we now look forward to the next phase, where we expect to see more patients respond favourably and with a consistently tolerable side effect profile. It appears that bridging to transplantation with long-term disease control can be achieved with confidence, given we can since perceive that the side effects reverse within a few weeks of the course being completed."

Race Clinical Advisory Board Chair Prof Borje Andersson
The trial will now progress to the Phase 2 efficacy (expansion) stage using a 4-day schedule of Zantrene (bisantrene dihydrochloride) in combination with fludarabine and clofarabine.

On May 26, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported it will present new data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating BMF-219’s activity in ex vivo preclinical models of CLL (Press release, Biomea Fusion, MAY 26, 2022, View Source [SID1234615164]). In addition, the company will present a Trial In Progress (TIP) poster presentation detailing the design of COVALENT-101. Once released at the ASCO (Free ASCO Whitepaper) Annual Meeting, the preclinical and TIP presentations can be viewed on Biomea’s website at View Source

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"Given our leadership team’s involvement with the discovery and development of ibrutinib and, thus, its demonstrated efficacy in CLL, we were highly encouraged to see BMF-219 demonstrate greater activity than ibrutinib ex vivo, especially in patient samples with TP53 alterations and NOTCH1 mutations," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. "BMF-219’s powerful cell-killing activity across ex vivo CLL models as a single agent, at similar concentrations as our prior experiments of BMF-219 in ex vivo models of other cancer types, is a very important finding. We are eager and very excited to fully explore the clinical potential of a covalent menin inhibitor across multiple liquid and solid tumor types."

BMF-219 demonstrated potency across ex vivo CLL tumor models with varying cytogenetic risk profiles and Rai stages, indicating broad activity with over 98% cell lethality in all of these models. Additionally, BMF-219 showed consistently strong activity compared to venetoclax (used as a positive control) and significantly greater activity than a clinical non-covalent (reversible) menin inhibitor. Additionally, BMF-219 exhibited robust growth inhibition in patient samples that were less responsive to bendamustine and ibrutinib.

Poster Presentation Details:

Preclinical activity of irreversible Menin inhibitor, BMF-219, in chronic lymphocytic leukemia. (Abstract #7541)
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session Date and Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
Full Text:
Background: Menin is a scaffold protein that drives oncogenic function through transcriptional modulation directed by its various cofactors. A previous report demonstrated that menin regulates a distinct set of gene targets independent of its function with the MLL proteins in hematopoiesis and is essential for B-cell maturation (Li et al.Blood.2013;122(12):2039-46.). Chronic Lymphocytic Leukemia (CLL) is a disease of malignant B lymphocytes, for which standard-of-care agents are generally well tolerated; however, CLL patients with certain genetic backgrounds demonstrate inferior outcomes to these regimens. A major driving feature of CLL is overexpression of the anti-apoptotic marker, BCL2. We previously reported the ability of BMF-219, a selective, irreversible menin inhibitor, to downregulate the expression of BCL2 in acute leukemia cells. Additionally, we have reported the synergy of BCL2-targeted agent, venetoclax, with BMF-219 in potent cell killing of diffuse large B-cell lymphoma (DLBCL) preclinical models, prompting our exploration of BMF-219 activity in CLL. Here, we provide the first preclinical evidence for menin as a therapeutic target in CLL, by demonstrating high potency of BMF-219 against a diverse collection of CLL patient specimens.

Methods: A comprehensive panel of CLL samples isolated from patients with Rai Stages 1 to 3 disease, including relapsed or refractory disease, were cultured ex vivo in the presence of BMF-219 or clinical reversible menin inhibitors to assess the antileukemic activity of the compounds. Samples were analyzed for differential gene expression of select targets in response to treatment.

Results: BMF-219 demonstrated high potency, achieving >98% cell lethality at 1 μM exposure in all patient samples tested, with IC50 values in the range of 0.1 to 0.38 μM. Specimens isolated from patients with clinical profiles of high-risk genetic backgrounds associated with inferior outcomes to standard therapy, such as mutations in TP53 and NOTCH1, and chromosomal aberrations such as del(13q), trisomy 12 and complex karyotype, exhibited high sensitivity to BMF-219 treatment. BMF-219 was also highly effective against patient samples with clinical profiles of resistance to bendamustine, ibrutinib and venetoclax therapy. In comparison, clinical reversible menin inhibitors demonstrated no significant activity across all patient samples tested, with incalculable IC50 values and <15% reduction in cell viability at 1 μM exposure. Expression of select target genes in treated CLL cell lines was explored and will be reported.

Conclusions: Collectively, our data demonstrate the potent preclinical activity of BMF-219 against CLL patient specimens harboring various mutational and cytogenetic backgrounds, including categories of high-risk. These data highlight the unique potential of irreversible menin inhibition as a novel therapeutic option for patients with CLL.

COVALENT-101: A phase 1 study of BMF-219, a novel oral irreversible menin inhibitor, in patients with relapsed/refractory (R/R) acute leukemia (AL), diffuse large B-cell lymphoma (DLBCL), and multiple myeloma (MM). (Abstract #TPS7064)
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session Date and Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
Full Text:
Background: Menin, a protein involved in transcriptional regulation, impacting cell cycle control, apoptosis, and DNA damage repair, plays a direct role in oncogenic signaling in multiple cancers. Inhibition of menin is therefore a novel approach to cancer treatment. Preclinical data of BMF-219, a highly selective, orally bioavailable, small-molecule irreversible inhibitor of menin, show sustained potent abrogation of menin-dependent oncogenic signaling in vitro and in vivo. BMF-219 exhibited a strong anti-proliferative effect on various menin-dependent acute myeloid leukemia (AML) cell lines, DLBCL lines representing Double/Triple Hit Lymphoma (DHL/THL) and Double Expressor Lymphoma (DEL), and MM cell lines with diverse mutational backgrounds. BMF-219 also showed high potency ex vivo in patient samples from MLL-rearranged and NPM1-mutant AML, THL and MYC-amplified DLBCL, and bone marrow mononuclear cells from treatment-naive and R/R MM.

Methods: COVALENT-101 (NCT05153330) is an open-label, multi-cohort, non-randomized, multicenter Phase I study evaluating the safety, tolerability, and clinical activity of escalating doses of once daily oral BMF-219 in patients with R/R AL, DLBCL and MM who have received standard therapy. Utilizing an accelerated titration design, doses of BMF-219 will be escalated in single-subject cohorts independently for each indication until 1 subject experiences either a ≥ Grade 2 related-adverse event or dose limiting toxicity (DLT). At that point, the cohort will switch to a classical "3 +3" design. Treatment will continue in 28-day cycles until progression or intolerability. Expansion cohorts for each indication will enroll patients to obtain further safety and efficacy data. Patients with R/R AL, R/R DLBCL ≥ 2 but ≤ 5 therapies, and R/R MM who received ≥ 3 therapies and failed or are ineligible for any standard therapies are eligible. Patients must have ECOG PS ≤ 2, and adequate organ function. Key exclusion criteria include known CNS disease involvement, prior menin inhibitor therapy, and clinically significant cardiovascular disease.

The primary objective is to determine independently for each cohort/indication the optimal biological dose (OBD)/ recommended Phase 2 dose (RP2D) of BMF-219 oral monotherapy. Key secondary objectives include further evaluation of safety and tolerability, characterization of the pharmacodynamics and pharmacokinetics of BMF-219, and assessment of its antitumor activity based on best overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and time to progression (TTP) per disease-specific response criteria as assessed by the investigator. Food-effect studies will be performed in DLBCL and MM patients at certain dose levels. The enrollment commenced in January 2022. Clinical trial information: NCT05153330.

About Chronic Lymphocytic Leukemia (CLL)

CLL is a chronic leukemia that progresses relatively slowly and typically impacts older adults. In the United States, approximately 20,000 patients are diagnosed with CLL each year. While the existing treatments options produce 5-year survival outcomes greater than 87%, there is an unmet need for patients that have high- or medium-risk cytogenetic profiles and those that are relapsed or refractory to existing treatments.

On May 26, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune, and infectious diseases reported it will deliver an oral presentation and two poster presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from June 3 – 7, 2022 (Press release, Immunocore, MAY 26, 2022, View Source [SID1234615163]).

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CLINICAL SCIENCE SYMPOSIUM

Title: Updated overall survival (OS) data from the phase 1b study of tebentafusp (tebe) as monotherapy or combination therapy with durvalumab (durva) and/or tremelimumab (treme) in metastatic cutaneous melanoma (mCM)

Presenter: Mark Middleton
Date and Time: June 5, 2022; 9:45 a.m. CDT
Session: Clinical Science Symposium: Bispecifics: Are two better than one?
Abstract ID: 104
POSTER PRESENTATIONS & ABSTRACTS

Title: Treatment with tebentafusp beyond radiographic progressive disease (PD) in metastatic uveal melanoma (mUM)

Presenter: Ryan Sullivan
Date and Time: June 6, 2022; 1:15 – 4:15 p.m. CDT
Session: Melanoma / Skin Cancers
Abstract ID: 9585
Title: Analysis of the effect of systemic corticosteroids on survival from tebentafusp in a phase 3 trial of metastatic uveal melanoma

Presenter: Alexandra Ikeguchi
Date and Time: June 6, 2022; 1:15 – 4:15 p.m. CDT
Session: Melanoma / Skin Cancers
Abstract ID: 9584
Title: Overall survival (OS) in metastatic uveal melanoma: A summary of recent prospective trials

Author: Josep M. Piulats
Publication only
Presentations and posters will be available for registered attendees on the ASCO (Free ASCO Whitepaper) website from June 3-7, 2022.

About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.

About KIMMTRAK
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma.

About Phase 3 IMCgp100-202 Trial
The IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK (tebentafusp-tebn) compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).

About ImmTAC Molecules
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.

On May 26, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines, reported an upcoming poster presentation of preliminary data from its ongoing Phase 2 VERSATILE-002 clinical trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022 in Chicago and online (Press release, PDS Biotechnology, MAY 26, 2022, View Source [SID1234615162]).

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VERSATILE-002 is a single-arm Phase 2 study evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune technology, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab). The combination is being evaluated in checkpoint inhibitor (CPI) -naïve and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). The data being presented at ASCO (Free ASCO Whitepaper) will detail preliminary safety and efficacy data for CPI-naïve patients at a prespecified interim analysis point.

In the VERSATILE-002 clinical trial, patients are being treated with KEYTRUDA 200 mg by IV infusion every three weeks, plus subcutaneous injection of PDS0101 for the first 4 treatment cycles (Cycles 1-4) and again on Cycle 12; KEYTRUDA treatment continues for up to 35 cycles, or until disease progression or demonstrated intolerance to therapy.

Highlights of the abstract from 19 patients (safety) with available imaging data for 17 of the 19 (efficacy) in the VERSATILE-002 clinical trial include:

Response rates thus far** (tumor shrinkage greater than 30%) seen in 7/17 (41.2%) patients in comparison to the published results of approximately 19% for approved checkpoint inhibitors used as monotherapy for recurrent or metastatic head and neck cancer, with 2 of the 7 having complete responses (CR)*
Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30%
Clinical efficacy (ORR** + SD) was seen in 13/17 (76.5%) patients
Progressive/ongoing disease was reported in 4/17 (23.5%) patients
Patients had received a median of 4/5 doses of PDS0101 (range 1-5) and 9/35 doses of KEYTRUDA (range 1-18)
There were no treatment-related adverse events greater than or equal to Grade 3 (N=19)
No patients required dose interruption or reduction on the combination treatment
No patients discontinued the combination treatment
At 9 months of follow up (median not yet achieved):
Progression free survival (PFS) rate was 55.2%
Overall survival (OS) rate was 87.2%
"While preliminary, we are excited to see the enhanced clinical responses and tolerability of PDS0101 in combination with KEYTRUDA in the CPI-naive arm of the VERSATILE-002 trial," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "We believe PDS0101’s ability to generate tumor-attacking killer T-cells without increasing toxicity based on these preliminary results speaks to the specificity of the Versamune-based immunotherapies and the potential of these drug candidates to work in combination with a broad range of anti-cancer therapies. These data continue to strengthen our confidence that PDS0101 in combination with KEYTRUDA could potentially improve patient outcomes."

"The clinical activity seen with PDS0101 in combination with KEYTRUDA thus far, in addition to the favorable safety profile continues to show promise in this difficult-to-treat patient population," stated Dr. Jared Weiss, MD, Lead Principal Investigator at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center. "While the patient pool is small, the responses we are seeing in these patients based on the preliminary results are significant, leading to shrinking of tumors, and extending overall survival."

The abstract for this poster is now available online on the ASCO (Free ASCO Whitepaper) conference website: View Source; data in this press release have been updated since the abstract submission.

Abstract/Poster Number: 6041
Poster Title: PDS0101 a novel type 1 interferon and CD8+ T-cell activating immunotherapy in combination with pembrolizumab in subjects with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).
Presenting Author: Jared Weiss, M.D., Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, who serves as the Lead Principal Investigator for VERSATILE-002
Session Title: Head and Neck Cancer
Date: Monday, June 6, 2022
Time: 1:15 PM-4:15 PM CDT

PDS Biotech is presenting a second abstract #2518 which presents clinical results for a PDS0101-based novel triple combination. The press release describing these data can be seen on the company website here.

The company is hosting a conference call on Tuesday, June 7 at 8:00 AM EDT to discuss the data from the two trials presented at ASCO (Free ASCO Whitepaper). To participate on the live call, please dial 877-407-3088 (US) or +1 201-389-0927 (International) and provide the conference ID "13729901" five to ten minutes before the start of the call. A live webcast of the event will be available online in the investor relations section of the company’s website at View Source

KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

*No control or comparative studies have been conducted between checkpoint inhibitors and PDS0101; Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B et al., Pembrplizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (keynote 048): a randomized, open label phase 3 study; Lancet 2019;394(10212):1915-1928
View Source
View Source
**The study is on-going and includes confirmed and unconfirmed responses.