On May 20, 2021 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX) reported that topline interim data from its Phase 2 trial of olutasidenib in relapsed/refractory acute myeloid leukemia (R/R AML) will be presented at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 4-8 (Press release, Forma Therapeutics, MAY 20, 2021, View Source [SID1234580390]). Olutasidenib, Forma’s selective inhibitor for cancers with mutations in isocitrate dehydrogenase 1 (IDH1m), demonstrated positive efficacy and a favorable tolerability profile as a monotherapy in patients with IDH1m R/R AML, achieving the primary endpoint of a composite complete remission (CR) or CR plus CR with partial hematologic recovery (CRh) rate of 33.3% (30% CR and 3% CRh).

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The presentation is based on an interim analysis from a pivotal trial arm evaluating continuous treatment with 150 mg twice daily of oral olutasidenib. The data indicate the duration of CR/CRh for people on treatment was 13.8 months. Among patients with a complete remission (CR) who were transfusion-dependent at baseline, 56-day transfusion independence was achieved in 100% of patients as measured by platelets and 83% as measured by red blood cells.

"The data being presented at ASCO (Free ASCO Whitepaper) showcase olutasidenib’s meaningful progress for this patient population, which currently has limited options to extend life expectancy," said Patrick Kelly, M.D., chief medical officer of Forma Therapeutics. "The safety data from the treatment cohort are consistent with the findings from our Phase 1 evaluation in this high-risk AML patient population. The data highlight the duration of response, which is nearly six months longer than current standard of care."

Oral Abstract Session – June 4, 2:30 p.m. ET

Abstract #7006: Effect of olutasidenib (FT-2102) on complete remissions in patients with relapsed/refractory (R/R) mIDH1 acute myeloid leukemia (AML): Results from a planned interim analysis of a phase 2 clinical trial
About the Phase 1/2 Study

The Phase 1/2 study is a multicenter, open-label, multi-cohort evaluation of the safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of olutasidenib for patients with AML or myelodysplastic syndrome (MDS) with an IDH1 mutation. Phase 1 of the trial, 2102-HEM-101, was an open-label, dose-escalation and expansion study of olutasidenib alone and in combination with azacitidine (AZA). The Phase 2 portion was an open-label, fixed-dose study of olutasidenib as a monotherapy and in combination with AZA in multiple IDH1m AML/MDS populations. The primary efficacy evaluable population is comprised of 123 R/R AML patients enrolled in Cohort 1, who received 150 mg of olutasidenib BID at least six months prior to the interim analysis cutoff date of June 18, 2020. The primary endpoint of the Phase 2 pivotal study is a complete remission (CR) plus a complete remission with partial hematological recovery (CRh) that is defined as <5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter).

Key Study Findings

Efficacy (n=123)

Olutasidenib induced a durable CR/CRh rate of 33.3% (95% CI 25.1, 42.2), which is the primary endpoint of the study:
The CR rate was 30.0% (37 of 123 patients) and the CRh rate was 3.0% (4 of 123 patients)
While the median duration of response was not yet reached, in a sensitivity analysis with hematopoietic stem cell transplant considered as the end of a response, the median duration was 13.8 months.
The median duration of overall response was 11.7 months.
The median overall survival (OS) was 10.5 months. The median OS for non-CR/CRh responders was 15.0 months. A median OS has not yet been reached for the CR/CRh population, with an 18-month survival estimate of 87.0%.
Transfusion independence was achieved in all response groups at 56 days, particularly in those achieving CR, with 100% independence for platelet transfusions and 83.0% independence for red blood cells.
Safety (n=153)

Olutasidenib was well-tolerated, with adverse events (AEs) consistent with the late stage disease and the heavily pre-treated population. A safety analysis for all 153 patients enrolled in the Phase 2 Cohort 1 found the most common grade 3/4 (≥ 20% or ≥ 10%) treatment-emergent adverse events (TEAEs) were febrile neutropenia (20%), anemia (19%), thrombocytopenia (16%), neutropenia (13%), leukocytosis (9%) and fatigue (<1%). AEs of interest were the following:
14% of patients reported AEs due to Differentiation syndrome, including 7% Grade 3 and 1% Grade 4 AEs. Most resolved with corticosteroids and treatment interruption. However, 1 fatal event was reported.
8% of patients reported AEs due to QTc prolongation, with <1% Grade 3 or 4. No events led to discontinuation.
Grade 3 or 4 elevation in liver parameters (ALT/AST/total bilirubin) occurred in 10% and 2% of patients, respectively. Most resolved with treatment interruption and dose reduction. Seven patients (<5%) discontinued study treatment due to LFT abnormalities. No Hy’s law cases reported.
About Olutasidenib

Olutasidenib is an oral, potent, small-molecule investigational agent designed to selectively bind to and inhibit mutated IDH1 enzymes. This targeted treatment has the potential to provide therapeutic benefit by reducing 2-HG levels and restoring normal cellular differentiation. With the conclusion of the Phase 2 R/R AML trial, Forma has begun preparing a new drug application (NDA) for submission to the U.S. Food and Drug Administration (FDA).

IDH1 is a natural enzyme that is part of the normal metabolism of all cells; when mutated, its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 6-8% of patients with AML and as many as 70 to 80% of patients with grade II/III gliomas and secondary glioblastoma. In gliomas, IDH1 mutations occur early in the tumor pathogenesis and persist throughout progression from a neural stem or progenitor cell. Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors, and high-grade gliomas are associated with poor long-term prognosis. Treatment options for relapsed glioma are limited.

On May 20, 2021 Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, reported that data from its first-in-human Phase 1 trial evaluating RBN-2397, its small molecule inhibitor of PARP7, as a monotherapy in patients with advanced solid tumors was selected for an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Ribon Therapeutics, MAY 20, 2021, View Source [SID1234580389]). Presenting the data will be Gerald S. Falchook, M.D., Director, Drug Development, Sarah Cannon Research Institute at HealthONE, Denver, CO and Clinical Investigator in the RBN-2397 Phase 1 trial. The full meeting program is available at: www.asco.org.

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"The data being presented at ASCO (Free ASCO Whitepaper) emphasizes the therapeutic potential of RBN-2397 as a novel inhibitor of PARP7 which aims to restore Type I interferon signaling in tumors and antitumor immunity. Our distinctive approach of targeting stress support pathways is a promising novel strategy for treating multiple types of cancer," said Victoria Richon, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. "We are encouraged that the data being shared show that RBN-2397 has been well tolerated with evidence of target engagement in the dose escalation portion of our Phase 1 trial and we look forward to providing future updates as the program advances in the clinic."

The data will be presented as follows:

Abstract Title: A first-in-human phase 1 study of a novel PARP7 inhibitor RBN-2397 in patients with advanced solid tumors
Session Date & Time: Friday, June 4, 2021 at 11:00 a.m. ET
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Presenter: Gerald S. Falchook, M.D., Director, Drug Development, Sarah Cannon Research Institute at HealthONE, Denver, CO and Clinical Investigator in the RBN-2397 Phase 1 trial
Abstract ID: 3000
Summary:

Targeting cytosolic nucleic acid sensing pathways and the Type I interferon (IFN) response is an emerging therapeutic strategy in oncology. PARP7 is a member of the monoPARP class of enzymes and a newly identified negative regulator of nucleic acid sensing in tumor cells. PARP7 expression is increased by cellular stress and aromatic hydrocarbons, and the PARP7 gene is amplified in multiple cancers. RBN-2397 is a potent, selective inhibitor of PARP7. To date, RBN-2397 is well tolerated and demonstrates dose dependent increases in plasma exposures, evidence of target inhibition and preliminary signs of clinical activity.
About RBN-2397
RBN-2397 is an orally available small molecule inhibitor of PARP7 that Ribon Therapeutics is developing for the treatment of solid tumors. PARP7 is upregulated in response to cellular stress, including genomic instability in cancers, and acts as a brake on the cellular stress response by negatively regulating the Type I interferon response. By inhibiting PARP7 in tumor cells, RBN-2397 has been shown to directly inhibit cellular proliferation and restore interferon signaling to stimulate an innate and adaptive antitumor immune response. RBN-2397 is currently in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors (NCT04053673). PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung, or SCCL, which represents approximately 30% of all non-small cell lung cancers.

On May 20, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported a publication describing the findings of a squamous cell carcinoma (SCC) gene expression profiling (GEP) expert panel in the Journal of Drugs in Dermatology (Press release, Castle Biosciences, MAY 20, 2021, View Source [SID1234580388]). The publication provides a framework for integrating DecisionDx-SCC into clinical practice.

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Treatment plan decisions in SCC are based upon the likelihood of an individual patient’s tumor to metastasize. Data from previous studies has demonstrated that DecisionDx-SCC, Castle’s prognostic 40-GEP test designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors, is a significant, independent predictor of risk, compared to existing traditional clinical and pathologic staging systems.

The article, titled "Clinical Considerations for Integrating Gene Expression Profiling into Cutaneous Squamous Cell Carcinoma Management," describes the findings of a multidisciplinary expert panel, representing backgrounds from academic medical centers and community practices. The panel also included specialties clinicians, such as Mohs surgeons, surgical oncologists and a radiation oncologist. The panel reviewed traditional risk assessment practices, guidelines and expert recommendations on DecisionDx-SCC. The panel also focused on decision-making points, where information from DecisionDx-SCC might inform the clinical management of patients with SCC and one or more risk factors.

Study findings:

Decision points supported by DecisionDx-SCC test results include:
nodal evaluation
adjuvant radiation therapy
follow-up and surveillance
The panel determined that the additional information provided by DecisionDx-SCC could:
help avoid unnecessary treatment and surveillance
allow healthcare providers to increase treatment intensity or follow-up as needed
inform if and when to refer a patient for medical, surgical, or radiation oncology
"This is an exciting time in the management of high-risk squamous cell carcinoma patients," said study author, Sherrif Ibrahim, M.D., Ph.D., Mohs surgeon and associate professor in the department of dermatology at The University of Rochester Medical Center. "Progress has been made with clinicopathologic risk factor assessment. However, potential remains for these assessments to overestimate or underestimate risk. Gene expression profile testing assists us in assessing the biologic risk of individual tumors and providing personalized care for our patients, which may lead to risk appropriate reduction of treatment or increased treatment intensity and more appropriate referrals."

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1, 2A or 2B risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

More information about the test and disease can be found at www.CastleTestInfo.com.

On May 20, 2021 Foundation Medicine, Inc. reported that the company and its collaborators will present a total of 29 studies, including two clinical science symposia presentations and two poster discussions, at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (ASCO21) from June 4-8 (Press release, Foundation Medicine, MAY 20, 2021, View Source [SID1234580387]). Among the presentations are data reinforcing the role of comprehensive genomic profiling (CGP) in increasing equitable patient access to precision medicine tools, as well as studies highlighting the clinical utility of CGP and the power of real-world data to inform treatment decisions and better understand disparities in care.

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Highlights of these presentations include:

new data emphasizing how the lack of early CGP testing and clinical trial enrollment in patients of African ancestry may help explain disparities in prostate cancer;
clinical data reinforcing the value of tissue- and liquid-based CGP as tools for oncologists to identify predictive biomarkers and enable precision medicine; and
additional evidence of the power of real-world data from Foundation Medicine and Flatiron Health’s joint clinico-genomic database (CGDB) to inform treatment decisions.
"At our core, Foundation Medicine is focused on using the highest quality insights to transform cancer care for everyone, and the breadth of data we’re presenting at ASCO (Free ASCO Whitepaper) in collaboration with our research and industry partners reflects that commitment," said Brian Alexander, M.D., M.P.H., CEO at Foundation Medicine. "The data we’ll share with the oncology community will help us continue moving the needle on changing clinical care by showing the clinical value of CGP across the spectrum of cancers, as well as highlighting the need to consistently and equitably improve access to genomic testing so that every person facing a cancer diagnosis has the insights needed to inform the best possible care."

Understanding Genomic Ancestry and CGP Utilization in Men with Prostate Cancer

In a study conducted in collaboration with Sylvester Comprehensive Cancer Center at the University of Miami, researchers investigated the genomic landscape and therapeutic implications of CGP in prostate cancer across men of European and African ancestry. Researchers believe this is the largest known cohort of its kind that describes CGP utilization, the genomic landscape from CGP, and treatment patterns in prostate cancer across ancestry groups. The analysis revealed men of African ancestry were less likely to receive CGP earlier in their treatment course and less likely to be treated in clinical trials. The findings potentially advance the field’s understanding of ancestry-based disparities in prostate cancer.

[Ancestral characterization of the genomic landscape, comprehensive genomic profiling utilization, and treatment patterns may inform disparities in advanced prostate cancer: A large-scale analysis. Abstract #5003.]

Clinical Utility of Comprehensive Genomic Profiling

In a study exploring the genomic and immunologic profile of intrahepatic cholangiocarcinoma (IHCC) with IDH1/2 genetic alterations in partnership with The University of Texas MD Anderson Cancer Center and others, researchers found significant differences in alterations between IDH1+/IDH2+ IHCC and IDH wild-type IHCC. The data suggest these alterations are IHCC driver oncogenes and support investigation of IDH inhibitors in these patients.

[IDH1 and IDH2 driven intrahepatic cholangiocarcinoma (IHCC): A comprehensive genomic and immune profiling study. Abstract #4009]

In a real-world clinical outcomes study of alpelisib in patients with PIK3CA-mutated breast cancer conducted in partnership with UCSF Helen Diller Family Comprehensive Cancer Center, researchers validated the effectiveness of alpelisib in a diverse, real-world population. Results showed these patients had longer progression-free survival with alpelisib plus fulvestrant than with fulvestrant alone. The study also showed liquid biopsy CGP detected PIK3CA mutations at a similar rate to tissue biopsy, reinforcing the clinical utility of both testing types depending on the patient’s unique situation.

[Real world (rw) clinical outcomes on alpelisib (ALP) in patients (pts) with breast cancer (BC) and PIK3CA mutations (PIK3CAm). Abstract #1068]

As the cancer community works to expand access to precision medicine trials to more patients, the need for decentralized trials has become increasingly apparent. In the Alpha-T study, a clinical trial sponsored by Roche using Foundation Medicine’s precision enrollment services, researchers at multiple institutions, including UCSD Moores Cancer Center and Vanderbilt University Medical Center, are investigating patients with ALK-positive solid tumors, identified through either liquid or tissue biopsy, being treated with alectinib. Through remote support, patients are participating in the trial from their local care setting, demonstrating the potential of decentralized trials to increase broader and more diverse enrollment in clinical trials.

[Alpha-T: An innovative decentralized (home-based) phase 2 trial of alectinib in ALK-positive (ALK+) solid tumors in a histology-agnostic setting. Abstract #TPS3155]

Power of Real-World Data to Advance Personalized Medicine

Using the CGDB, researchers assessed outcomes for metastatic breast cancer patients with somatic BRCA or other homologous recombination (HR)-pathway mutations treated with a PARP inhibitor. Results suggested these patients had similar benefit from PARP inhibitor treatment compared to patients with germline BRCA mutations, supporting future studies of this targeted treatment approach for these patients.

[Analysis of real-world (RW) data for metastatic breast cancer (mBC) patients (pts) with somatic BRCA1/2 (sBRCA) or other homologous recombination (HR)-pathway gene mutations (muts) treated with PARP inhibitors (PARPi). Abstract #10512]

Leveraging routine CGP testing of metastatic castrate resistant prostate (mCRPC) cancer tissue samples, researchers discovered that patients with biomarkers routinely assessed by CGP, including AR amplification, may help predict which patients are likely to benefit from taxane chemotherapy instead of novel hormonal therapy.

[Using real-world outcomes to evaluate the predictive power of tissue-assessed genomic biomarkers for taxane versus novel hormonal therapy (NHT) outcomes in metastatic castration-resistant prostate cancer (mCRPC). Abstract #5054]

The following is a list of select abstracts that will be presented at the meeting. To access all abstracts being presented by Foundation Medicine and its collaborators, please visit: meetinglibrary.asco.org.

Abstract #

Title

Collaborator

Clinical Science Symposia

5003

Ancestral characterization of the genomic landscape, comprehensive genomic profiling utilization, and treatment patterns may inform disparities in advanced prostate cancer: A large-scale analysis.

University of Michigan Cancer Center, Sylvester Comprehensive Cancer Center, Harvard Medical School

4009

IDH1 and IDH2 Driven Intrahepatic Cholangiocarcinoma (IHCC): A comprehensive genomic and immune profiling study.

MD Anderson

Poster Discussions

10512

Analysis of real-world (RW) data for metastatic breast cancer (mBC) patients (pts) with somatic BRCA1/2 (sBRCA) or other homologous recombination (HR)-pathway gene mutations (muts) treated with PARP inhibitors (PARPi).

Beth Israel Deaconess Medical Center; Dana Farber Cancer Institute, Flatiron

3009

Prevalence of inferred clonal hematopoiesis (CH) detected on comprehensive genomic profiling (CGP) of solid tumor tissue or circulating tumor DNA (ctDNA).

Poster Presentations

5054

Using real-world outcomes to evaluate the predictive power of tissue-assessed genomic biomarkers for taxane versus novel hormonal therapy (NHT) outcomes in metastatic castration-resistant prostate cancer (mCRPC).

MD Anderson

5567

Assessment of predictive biomarker prevalence in molecularly defined adult-type ovarian granulosa cell tumors.

MD Anderson

TPS3143

TCF-001 TRACK (Target Rare Cancer Knowledge): A national patient-centric precision oncology trial for rare cancers.

University of California San Diego, TargetCancer Foundation​

TPS3155

Alpha-T: An innovative decentralized (home-based) phase 2 trial of alectinib in ALK-positive (ALK+) solid tumors in a histology-agnostic setting.

Roche,​ UCSD Moores Cancer Center, Vanderbilt University Medical Center

2599

Real-world pan-cancer landscape of frameshift mutations (FSM) and their role in predicting responses to immune checkpoint inhibitors (ICI) in patients (pts) with tumors with low tumor mutational burden (TMB).

​Huntsman Cancer Institute

1068

Real-world (rw) clinical outcomes on alpelisib (ALP) in patients (pts) with breast cancer (BC) and PIK3CA mutations (PIK3CAm).

University of California, San Francisco

2541

Genomic immunotherapy (IO) biomarkers detected on comprehensive genomic profiling (CGP) of tissue and circulating tumor DNA (ctDNA).

National Cancer Center Hospital East; Kashiwa, Japan

1036

Concordance of HER2+ status by IHC/ISH and ERBB2 status by NGS in a real-world clinicogenomic database and analysis of outcomes in patients (pts) with metastatic breast cancer (mBC).

Flatiron

539

Comprehensive genomic profiling (CGP) of 275 male breast cancer (BC) tissue (TBx) and liquid (LBx) biopsies: Comparative analysis to a female cohort (FBC) and therapeutic considerations.

Dana Farber Cancer Institute

9101

Identification of potential germline (GL) variants by routine clinical comprehensive genomic profiling (CGP) and confirmatory GL testing in 24 tumor types.

Dana Farber Cancer Institute

On May 20, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that new data from two clinical trials evaluating the company’s lead asset NT-I7 (efineptakin alfa) will be presented during poster sessions at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held in a virtual platform June 4-8, 2021 (Press release, NeoImmuneTech, MAY 20, 2021, View Source [SID1234580386]). The data come from clinical studies evaluating NT-I7, a novel long-acting human IL-7, 1. in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as a treatment for advanced solid tumors, and 2. given concurrently with adjuvant chemotherapy in patients with high-grade gliomas.

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Details related to the poster presentations are as follows:

Title: Safety, Pharmacokinetics, Pharmacodynamics Profiles and Preliminary Antitumor Activity of Phase 1b/2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab in Patients with Advanced Solid Tumors: The Phase 1b Data Report
Lead Author: Aung Naing, MD, The University of Texas MD Anderson Cancer Center
Abstract Number: 2594
Poster Session: Developmental Therapeutics—Immunotherapy, on demand starting at 9:00am ET, June 4, 2021

Title: A phase I/II study to evaluate the safety and efficacy of a novel long-acting interleukin-7, NT-I7, for patients with newly diagnosed high-grade gliomas after chemoradiotherapy: the interim result of the phase I data
Lead Author: Jian Li Campian, MD, PhD, Washington University School of Medicine in St. Louis/Siteman Cancer Center
Abstract Number: 2040
Poster Session: Central Nervous System Tumors, on demand starting at 9:00am ET, June 4, 2021

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.