On May 20, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on May 19, 2021 for FoundationOne Liquid CDx Cancer Genomic Profile to be used as a companion diagnostic for the PARP inhibitor, Lynparza (generic name: olaparib) for the treatment of BRCA-mutated castrate-resistant prostate cancer (mCRPC) with distant metastasis (Press release, Chugai, MAY 20, 2021, View Source [SID1234580339]). With this approval, patients with advanced prostate cancer who may be eligible for the treatment with olaparib can be identified through both tissue-based and liquid-based comprehensive genomic profiling (CGP) tests. Since tissue availability can be an issue for some metastatic prostate cancer patients, blood-based testing is an important option to consider and critically important for informing patient care.

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"We are pleased that the FoundationOne Liquid CDx Cancer Genomic Profiletest was approved as a companion diagnostic for olaparib for advanced metastatic prostate cancer, following the tissue-based FoundationOne CDx Cancer Genomic Profile approval in December last year," said Chugai’s President and CEO, Dr. Osamu Okuda. "Precision cancer medicine is rapidly changing the treatment strategy for mCRPC and it is very important to understand the genomic profile of a patient’s tumor in order to select the optimal treatment. The availability of both liquid and tissue-based companion diagnostics helps to identify patients who may be eligible for olaparib. We are committed to advancing personalized healthcare in cancer treatment."

The approval aims to expand the use of FoundationOne Liquid CDx Cancer Genomic Profile as a companion diagnostic for olaparib in advanced prostate cancer which progressed after treatment with enzalutamide or abiraterone. It identifies patients who my be eligible for the treatment by detecting BRCA1/2 gene alterations. The efficacy and safety of olaparib in mCRPC patients with BRCA1/2 alterations were investigated in the Phase III PROfound study and AstraZeneca K.K. received approval from the MHLW on December 25, 2020. Olaparib is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and MSD (Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA).

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized healthcare in oncology and contributing to patients and healthcare professionals through improving access to CGP.

Approval information The underlined part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of blood samples in patients with solid tumors.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate
EGFR exon 20 T790M alterations osimertinib mesilate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alterations Prostate cancer olaparib
About FoundationOne Liquid CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device using blood samples for advanced cancer patients with solid tumors. It is intended to identify genomic alterations in 324 cancer-related genes through detection of circulating tumor DNA (ctDNA) in blood. The test is approved by the MHLW for use in cancer genome profiling to report substitutions, insertion and deletion alterations, and select gene rearrangements for short variants in 324 genes. It is also indicated for use as a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table above of Intended uses or indications). For the latest information about the product, including companion diagnostic indications, please refer to the prescribing information.

About BRCA alterations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genomic stability of cells. When either of these genes is mutated or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genomic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.1-4

Trademarks used or mentioned in this release are protected by laws.

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 On Target Laboratories, Inc., a privately held biotechnology company developing fluorescent markers to target and illuminate cancer during surgery, reported results of the 006 Study, a Phase 3, randomized, multi-center, prospective, open-label study to investigate the safety and efficacy of pafolacianine sodium injection (OTL38) for intraoperative imaging of folate receptor positive ovarian cancer (Press release, On Target Laboratories, MAY 20, 2021, View Source [SID1234580405]).

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In 33% of patients (36 of 109), near-infrared imaging with pafolacianine sodium injection identified additional lesions which would have been left behind (P < 0.001, 95% CI [0.243, 0.427]). Among patients who underwent interval debulking surgery, the rate was higher, at 39.7% of patients (23 of 58; 95% CI [0.270, 0.534]).

"We are proud to share the results of the Phase 3 trial for pafolacianine sodium injection in ovarian cancer, which demonstrated identification of additional cancer that was not planned for resection," said Chris Barys, Chief Executive Officer of On Target Laboratories. "These results get us closer to realizing our mission to make cancer visible during surgery so it can be removed more completely."

The data will be presented on June 7 during the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract # 5503).

"The surgeon’s ability to achieve a complete resection in ovarian cancer patients impacts their long-term prognosis," said Dr. Janos L. Tanyi, MD, PhD, an Assistant Professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania and Principal Investigator of the trial. "The trial results add to the body of evidence supporting the potential of pafolacianine sodium injection as an adjunct to identify malignant lesions that may otherwise be missed."

About the Phase 3 006 Study

In the Phase 3, randomized, multi-center, open-label study, patients with ovarian cancer who were scheduled to undergo cytoreductive surgery were recruited from 11 sites in the US and Netherlands from March 2018 through April 2020. The primary endpoint was the percent of patients in which ≥1 folate receptor positive ovarian cancer lesion was detected by intraoperative fluorescence imaging on tissue not planned for resection and not detected by normal white light or palpation.

This phase 3 trial of pafolacianine sodium injection with near-infrared imaging met its primary endpoint, intraoperatively identifying additional cancer not planned for resection in a statistically significant number of patients.

The safety profile observed was consistent with the Phase 2 trial published in 2019.1 The most frequently reported drug-related adverse events (AEs) were nausea (18.0%), vomiting (5.3%), and abdominal pain (4.7%). The majority (97%) of drug-related AEs were mild or moderate in severity and were transient in nature. No drug-related serious AEs or deaths were reported.

On May 20, 2021 Processa Pharmaceuticals, Inc. ("Processa") presented the corporate presentation (Presentation, Processa Pharmaceuticals, MAY 20, 2021, View Source [SID1234580422]).

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On May 20, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the latest data regarding its oncology pipeline and products including in-house discovered lenvatinib mesylate (multikinase inhibitor, product name: LENVIMA, "lenvatinib") and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: HALAVEN, "eribulin") will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (2021 ASCO (Free ASCO Whitepaper) Annual Meeting*), to be held virtually from June 4 to 8, 2021 (Press release, Eisai, MAY 20, 2021, View Source [SID1234580340]).

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* Abstracts will be made available on demand via ASCO (Free ASCO Whitepaper)’s website at 5:00 PM on May 19th (ET).

At this meeting, there will be an oral presentation on the analysis of health-related quality-of-life (HRQoL) (Abstract No: 4502) of the pivotal Phase 3 CLEAR Study (Study 307/KEYNOTE-581) evaluating lenvatinib in combination with pembrolizumab (product name: KEYTRUDA, "pembrolizumab"), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma. Additionally, respective CLEAR poster presentations on analysis of depth of response and efficacy (Abstract No: 4560) and a post hoc analysis of effects of subsequent systemic anticancer medication (Abstract No: 4562) will be presented.

In addition, a poster presentation on the analysis of HRQoL (Abstract No: 5570) of the pivotal Phase 3 Study 309/KEYNOTE-775 evaluating lenvatinib in combination with pembrolizumab versus chemotherapy (treatment of physician’s choice [TPC]) for the treatment of patients with advanced endometrial carcinoma (advanced uterine body cancer in Japan), following at least one prior platinum-based regimen is planned.

An oral presentation on results of the latest analysis of a Phase 2 study (LEAP-004) evaluating lenvatinib in combination with pembrolizumab for the treatment of patients with advanced melanoma who had been treated with an anti-PD-1 or PD-L1 immune checkpoint inhibitor (Abstract No: 9504) is also planned.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

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.

Lenvatinib Plus Pembrolizumab Combination Therapy Abstract Topics

Cancer Type Abstract Type
Abstract No. Presentation Topic

Renal Cell Carcinoma

Oral Presentation

Abstract No: 4502
Health‐related quality‐of‐life (HRQoL) analysis from the phase 3 CLEAR trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) or everolimus (EVE) vs sunitinib (SUN) for patients (pts) with advanced renal cell carcinoma (aRCC) (Study 307/KEYNOTE-581)

Presentation Session: June 7 (Mon.) 8:00-11:00 AM EDT
Poster

Abstract No: 4560
Analysis of the CLEAR study in patients (pts) with advanced renal cell carcinoma (RCC): depth of response and efficacy for selected subgroups in the lenvatinib (LEN) + pembrolizumab (PEMBRO) and sunitinib (SUN) treatment arms (Study 307/KEYNOTE-581)

Poster

Abstract No: 4562
Post hoc analysis of the CLEAR study in advanced renal cell carcinoma (RCC): Effect of subsequent therapy on survival outcomes in the lenvatinib (LEN) + everolimus (EVE) vs sunitinib (SUN) treatment arms (Study 307/KEYNOTE-581)

Online Publication

Abstract No: e16542
Lenvatinib (LEN) + pembrolizumab (PEMBRO) treatment in patients (pts) with metastatic clear cell renal cell carcinoma (RCC): Final results of a phase 1b/2 trial (Study 111/KEYNOTE-146)

Poster

Abstract No: TPS4594* A phase 1b/2 umbrella study of investigational immune and targeted combination therapies as first-line therapy for patients with advanced renal cell carcinoma (RCC)
Poster

Abstract No: TPS4595*
KEYNOTE-B61: Open-label phase 2 study of pembrolizumab in combination with lenvatinib as first-line treatment for non-clear cell renal cell carcinoma (nccRCC) (KEYNOTE-B61)

Endometrial Carcinoma

Poster

Abstract No: 5570
Health-related quality of life (HRQoL) in advanced endometrial cancer (aEC) patients (pts) treated with lenvatinib plus pembrolizumab or treatment of physician’s choice (TPC) (Study 309/KEYNOTE-775)

Online Publication

Abstract No: e17571 Systematic literature review of the real-world burden and use of chemotherapies for treatment of advanced or recurrent endometrial carcinoma
Poster

Abstract No: 5581 Treatment patterns and outcomes among patients with microsatellite stable (MSS) advanced endometrial cancer in the United States: Endometrial Cancer Health Outcomes (ECHO) retrospective chart review Study
Melanoma
Oral Presentation

Abstract No: 9504
Lenvatinib (LEN) plus pembrolizumab (pembro) for patients (pts) with advanced melanoma and confirmed progression on a PD-1 or PD-L1 Inhibitor: Updated findings of LEAP-004 (LEAP-004 Study)

Presentation Session: June 7 (Mon.) 8:00-11:00 AM EDT
Hepatocellular Carcinoma
Poster

Abstract No: 4084 Exploratory circulating biomarker analyses: lenvatinib + pembrolizumab (L + P) in a phase 1b trial in unresectable hepatocellular carcinoma (uHCC) (116 Study)
Gastric Cancer
Poster

Abstract No: 4030
LEAP-005: A phase 2 multicohort study of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors—Results from the gastric cancer cohort (LEAP-005 Study)

Colorectal Cancer
Poster

Abstract No: 3564
LEAP-005: A phase 2 multicohort study of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors—Results from the colorectal cancer cohort (LEAP-005 Study)

Biliary Tract Cancer
Poster

Abstract No: 4080
Lenvatinib plus pembrolizumab for patients with previously treated biliary tract cancers in the multicohort phase 2 LEAP-005 study

(LEAP-005 Study)
* The presentation with TPS (Trial in Progress Submission) attached to the abstract number indicates that the study is in the intermediate stage, and the presentation does not report the final study results.

Lenvatinib Monotherapy Poster Presentation Topics

Cancer Type Abstract Type
Abstract No. Presentation Topic

Hepatocellular

Carcinoma

Poster

Abstract No: 4098

The cost effectiveness of lenvatinib versus atezolizumab and bevacizumab or sorafenib in patients with unresectable hepatocellular carcinoma (uHCC) in Canada

Online Publication

Abstract No: e16129

Real-world effectiveness of lenvatinib monotherapy among previously treated unresectable hepatocellular carcinoma patients in United States clinical practices
Online Publication

Abstract No: e16119

Impact of bodyweight (BW)-based starting doses on safety and efficacy of lenvatinib (LEN) in patients (pts) with hepatocellular carcinoma (HCC (304/202 Study)
Online Publication

Abstract No:

e16151

The comparative efficacy of atezolizumab and bevacizumab vs. lenvatinib in patients with unresectable hepatocellular carcinoma (uHCC)
Online Publication

Abstract No:

e16118 A multicenter observational study of Lenvatinib for unresectable hepatocellular carcinoma in Japan

Eribulin Poster Presentation Topics

Cancer Type Abstract Type
Abstract No. Presentation Topic
Breast Cancer
Online Publication

Abstract No:

e13058
Real-world clinical effectiveness of eribulin in metastatic breast cancer patients with visceral metastases in the United States

Gastric Cancer
Poster

Abstract No:

4025
Phase 1 study of the liposomal formulation of eribulin (E7389-LF): Results from the advanced gastric cancer expansion cohort (Study 114)

Pipeline and Other Poster Presentation Topics

Abstract Type
Abstract No. Presentation Topic
Online Publication

Abstract No: e18836
Health care cost impact associated with adverse events (AEs) among treatments in third-line+ (3L+) relapsed/refractory follicular lymphoma (R/R FL)

Poster

Abstract No: 4090 Phase I study of H3B-6527 in hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC) (Study 101)
Online Publication

Abstract No: e13025 Phase 1b study of H3B-6545 in combination with palbociclib in women with metastatic estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer (Study 102)
Online Publication

Abstract No: e13022 Relative bioavailability of H3B-6545 tablets versus capsules and drug-drug interaction between H3B-6545 and pantoprazole (Pharmacokinetics Study)
Poster

Abstract No: 1018 Phase I/II study of H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (Study 101)
Poster

Abstract No: 11039 Impact of #ASCO Twitter Impressions on the Oncology Community
Online Publication

Abstract No: e18521
Perspectives on under-representation of minority patients (pts) in clinical trials

About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration
In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., 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 LENVIMA (lenvatinib). Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA (pembrolizumab), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.

In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in 14 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, pancreatic cancer and triple-negative breast cancer) across more than 20 clinical trials.

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