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.

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, Aclaris Therapeutics, Inc. (the "Company") reported that it entered into a Sales Agreement (the "Agreement") with SVB Leerink LLC ("SVB Leerink") and Cantor Fitzgerald & Co. ("Cantor") under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.00001 per share (the "Common Stock"), having an aggregate offering price of up to $150,000,000 through SVB Leerink and Cantor as its sales agents (Filing, 8-K, Aclaris Therapeutics, MAY 20, 2021, View Source [SID1234580423]). The issuance and sale, if any, of Common Stock by the Company under the Agreement will be made pursuant to a registration statement on Form S-3.

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SVB Leerink and Cantor may sell the Common Stock by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act of 1933, as amended. SVB Leerink and Cantor will use commercially reasonable efforts to sell the Common Stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay SVB Leerink and Cantor a commission equal to three percent (3.0%) of the gross sales proceeds of any Common Stock sold through SVB Leerink and Cantor under the Agreement. The Company has provided customary representations, warranties and covenants and the parties have agreed to customary indemnification rights.

The Company is not obligated to make any sales of Common Stock under the Agreement. The offering of shares of Common Stock pursuant to the Agreement will terminate upon the earlier of (i) the sale of all Common Stock subject to the Agreement or (ii) termination of the Agreement in accordance with its terms.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.