On May 17, 2018 Flatiron Health reported 11 abstracts accepted for presentation at the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held June 1-5 in Chicago (Press release, Flatiron Health, MAY 17, 2018, View Source [SID1234526783]). The research, spanning multiple tumor types and areas of study, utilized Flatiron’s highly-curated, nationally-representative, real-world oncology datasets, the largest in the United States.

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The research to be presented includes collaborations with the Abramson Cancer Center of the University of Pennsylvania, Fred Hutchinson Cancer Research Center, Genentech (a member of the Roche Group), Huntsman Cancer Institute at the University of Utah, the National Cancer Institute, Roche, the U.S. Food & Drug Administration, and Yale Cancer Center.

The presentation schedule and links to abstracts can be found below. To learn more about Flatiron Health, visit our booth #2049 during the conference or click here.

Oral Presentation

Application of a real-world endpoint to identify and characterize genetic profiles of patients (pts) with poor prognosis in advanced non-small-cell lung cancer (aNSCLC)

Presenting Author: Greg Riely (Memorial Sloan Kettering Cancer Center)
Date/Time: 6/5/2018, 10:00 – 10:12 AM
Abstract: #12006
Location: S406
Session: Tumor Biology

Poster Discussion Presentation

Cost-effectiveness of multi-gene panel sequencing (MGPS) for advanced non-small cell lung cancer (aNSCLC) patients

Presenting Author: Lotte Steuten (Fred Hutchinson Cancer Research Center)
Date/Time: 6/2/2018, 4:45 – 6:00 PM
Abstract: #6513
Poster: #339
Location: S102
Session: Health Services Research, Clinical Informatics, and Quality of Care

Poster Presentations (Location: Hall A)

Real-world (RW) characteristics, treatment (tx) patterns, and overall survival (OS) in US patients (pts) with metastatic breast cancer (mBC) and CNS metastases (CNS mets)

Presenting Author: Ashwini Shewade (Genentech, a member of the Roche Group)
Date/Time: 6/2/2018, 8:00 – 11:30 AM
Abstract: #1037
Poster: #118
Session: Breast Cancer—Metastatic

Diffusion of innovation in oncology: A case study of immuno-oncology (IO) adoption for advanced non-small lung cancer (aNSCLC) patients across practices in the US

Presenting Author: Carrie Bennette (Flatiron Health)
Date/Time: 6/2/2018, 1:15 – 4:45 PM
Abstract: #6537
Poster: #363
Session: Health Services Research, Clinical Informatics, and Quality of Care

Association of baseline body mass index (BMI) with overall survival (OS) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) treated with nivolumab (N) and pembrolizumab (P)

Presenting Author: Jizu Zhi (U.S. Food & Drug Administration)
Date/Time: 6/2/2018, 1:15 – 4:45 PM
Abstract: #6553
Poster: #379
Session: Health Services Research, Clinical Informatics, and Quality of Care

Development of a dashboard for end-of-life care at an academic hospital

Presenting Author: Kerin Adelson (Yale Cancer Center)
Date/Time: 6/2/2018, 1:15 PM – 4:45 PM
Abstract: #6590
Poster: #415
Session: Health Services Research, Clinical Informatics, and Quality of Care

Real-world data (RWD) on tumor response (rwTR) in advanced non-small cell lung cancer (aNSCLC) patients receiving cancer immunotherapy and targeted therapies

Presenting Author: Michael W Lu (Genentech, a member of the Roche Group)
Date/Time: 6/2/2018, 1:15 – 4:45 PM
Abstract: #6578
Poster: #403
Session: Health Services Research, Clinical Informatics, and Quality of Care

Comparative effectiveness of carboplatin-pemetrexed (carbo-pem) with vs without bevacizumab (bev) in patients with advanced non-squamous (sq) non-small cell lung cancer (NSCLC)

Presenting Author: Stephen Bagley (Abramson Cancer Center of the University of Pennsylvania)
Date/Time: 6/3/18, 8:00 – 11:30 AM
Abstract: #9073
Poster: #396
Session: Lung Cancer—Non-Small Cell Metastatic

Age-related real-world outcomes for patients (pts) with metastatic colorectal cancer (mCRC)

Presenting Author: Rebecca Miksad (Flatiron Health)
Date/Time: 6/3/2018, 8:00 – 11:30 AM
Abstract: #3613
Poster: #106
Session: Gastrointestinal (Colorectal) Cancer

Immune checkpoint inhibitor (ICI) treatment in advanced melanoma (aMel) patients (pts) with hepatic or renal dysfunction (dysf): Real-world patient characteristics and outcomes

Presenting Author: Susan Spillane (National Cancer Institute)
Date/Time: 6/4/2018, 1:15 – 4:45 PM
Abstract: #9569
Poster: #396
Session: Melanoma/Skin Cancers

Risk stratification using patient-reported outcomes (PROs) in patients (pts) with advanced cancer

Presenting Author: Shiven Patel (Huntsman Cancer Institute at the University of Utah)
Date/Time: 6/4/2018, 1:15 – 4:45 PM
Abstract: #10101
Poster: #89
Session: Patient and Survivor Care

On May 17, 2018 Ipsen (Euronext: IPN; ADR: IPSEY) reported that the European Commission (EC) has approved Cabometyx (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma (aRCC) (Press release, Ipsen, MAY 17, 2018, View Source [SID1234650566]). This approval allows for the marketing of Cabometyx (cabozantinib) in this indication in all 28 member states of the European Union, Norway and Iceland.

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"Today’s EC approval is a step forward for advanced kidney cancer patients in Europe who will be able to access a new oral first-line treatment option that offers significant improvement over the standard of care", said Harout Semerjian, Executive Vice President, Chief Commercial Officer, Ipsen. "Ipsen remains committed to improving patients’ lives by continuing to develop new therapies and expanding the potential of Cabometyx across different indications."

Giuseppe Procopio, M.D., Head of the Genitourinary Unit at Fondazione Istituto Nazionale Tumori Milan, stated: "The value of treatment with Cabometyx has been corroborated by the data generated in clinical trials, and since 2016 physicians have also witnessed the potential of it when treating patients following VEGF-targeted therapy. For both of these reasons, physicians will be pleased to soon have access to this new first-line treatment option for intermediate- or poor- risk advanced RCC patients."
Today’s decision is based on the CABOSUN trial, which demonstrated that cabozantinib significantly prolongs progression-free survival (PFS) compared to sunitinib in treatment-naive aRCC patients with intermediate- or poor-risk. Cabozantinib is the first and only monotherapy to demonstrate superior clinical efficacy over sunitinib in treatment-naïve aRCC patients with intermediate- or poor-risk.
The detailed recommendations for the use of this product are described in the Summary of Product Characteristics (SmPC), available here (View Source).
About the CABOSUN study
On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS compared with sunitinib in patients with intermediate- or poor-risk aRCC per IMDC (International Metastatic RCC Carcinoma Database Consortium) criteria as determined by investigator assessment. CABOSUN was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the NCI-CTEP. These results were first presented by Dr. Toni Choueiri at the meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016, and published in the Journal of Clinical Oncology (Choueiri, JCO, 2018).i
On June 19 2017 Exelixis announced that the analysis of the review by a blinded independent radiology review committee (IRC) has confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival (PFS) from the CABOSUN randomized phase 2 trial of cabozantinib as compared with sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria. Per the IRC analysis, cabozantinib demonstrated a clinically meaningful and statistically significant reduction in the rate of disease progression or death as measured by PFS. The incidence of adverse events (any grade) and the incidence of grade 3 or 4 adverse events between cabozantinib and sunitinib were comparable.
CABOSUN is a randomized, open-label, active-controlled phase II trial that enrolled 157 patients with aRCC determined to be intermediate- or poor-risk per IMDC criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, four weeks on followed by two weeks off). The primary endpoint was PFS. Secondary endpoints included overall survival and objective response rate. Eligible patients were required to have locally advanced or metastatic clear-cell RCC, ECOG performance status 0-2, and had to be intermediate- or poor-risk per IMDC criteria (Heng, JCO, 2009).ii Prior systemic treatment for RCC was not permitted.
About advanced Renal Cell Carcinoma
With the incidence predicted to rise 22% by 2020, renal cell carcinoma (RCC) threatens to become one of the fastest growing cancers in the world.iii Targeted therapies including tyrosine kinase inhibitors (TKIs) of the VEGF receptor (VEGFR) introduced a decade ago, significantly transformed the treatment landscape of aRCC.iv
The American Cancer Society’s 2017 statistics cite kidney cancer as one of the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.v Clear cell RCC is the most common type of kidney cancer in adults.vi If detected in its early stages, the five-year survival rate for RCC is high. For patients with advanced- or late-stage metastatic RCC, however, the five-year survival rate is only 12% with no identified cure for the disease.vii Approximately 30,000 patients in the U.S. and 68,000 globally require treatment.viii
The majority of clear cell RCC tumors have lower than normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL, and VEGF.ix–x These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness, and metastasis.xi, xii, xiii, xiv MET and AXL may provide escape pathways that drive resistance to VEGFR inhibitors. xii – xv
About CABOMETYX (cabozantinib)
Cabometyx is an oral small molecule inhibitor of receptors, including VEGFR, MET, AXL and RET. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance.
In February of 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan. This agreement was amended in December of 2016 to include commercialization rights for Ipsen in Canada. On April 25, 2016, the FDA approved Cabometyx tablets for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy and on September 9, 2016, the European Commission approved Cabometyx tablets for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland. Cabometyx is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily.
On December 19, 2017, Exelixis received approval from the FDA for Cabometyx for the expanded indication of treatment of advanced RCC.
On May 17, 2018, Ipsen announced that the European Commission approved Cabometyx for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinomain the European Union, Norway and Iceland.

On May 17, 2018 During the Congress of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) that will be held form the 1st to the 5th of June in Chicago (USA), PharmaMar reported it will present the data obtained from various clinical studies of the molecules Yondelis , lurbinectedin (PM1183) and plitidepsin (Press release, PharmaMar, MAY 17, 2018, View Source [SID1234526748]).

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Two studies carried out with Yondelis (trabectedin) will be presented, including an oral presentation by the French Sarcoma Group on the results of aprospective phase III study comparing trabectedin versus best supportive care in patients with soft tissue sarcoma. And the design of the phase I/II safety and efficacy study
using the triple combination of trabectedin, ipilimumab and nivolumab for the first line treatment of soft tissue sarcoma. PharmaMar will also have data for lurbinectedin (PM1183), presenting the clinical
advances made in indications such as Ewing´s sarcoma, breast cancer and smallcell lung cancer, which is currently in a pivotal phase III clinical trial called ATLANTIS that should complete recruitment in Q3.

The studies that will be presented during the meeting are available at View Source Studies highlighted at ASCO (Free ASCO Whitepaper) 2018

Lurbinectedin

Lurbinectedin is a compound under clinical investigation which is an inhibitor of the RNA polymerase II enzyme which is essential for the transcription process. It’s inhibition suppresses tumor growth, and results in tumor death. The antitumor efficacy of PM1183 is being investigated in various types of solid tumors.

• Efficacy and safety of lurbinectedin (PM1183) in Ewing sarcoma:
Final results from a phase 2 study. (Abstract #11519)
Poster Board: #264. Saturday, June 2. 15:00 to 16:15. Hall A
Discussed at the Poster Discussion Sessuon on Satuday, June 2, from 15:00
to 16:15 at S404
Lead author: Vivek Subbiah, MD. The University of Texas MD Anderson
Cancer Center

• Antitumor activity of PM1183 (lurbinectedin) in combination with capecitabine in metastatic breast cancer patients: results from a Phase I trial. (Abstract #1072)
Poster board: #153. Saturday, June 2. 8:00 a.m. to 11:30 a.m. Hall A.
Lead author: Ahmad Awada, MD, PhD. Medical oncology Clinic, Institut Jules
Bordet, Université Libre de Bruxelles

• Efficacy and safety of lurbinectedin (PM1183) in small cell lung cancer (SCLC): Results from a phase 2 study. (Abstract #8570)
Poster board: #176. Sunday, June 3. 8:00 a.m to 11:30. Hall A.
Lead author: Jose Manuel Trigo Perez, MD. Hospital Virgen de la Victoria,
Spain.

• ATLANTIS: Global, randomized phase III study of lurbinectedin (L) with doxorubicin (DOX) vs. CAV or topotecan (T)in small-cell lung
cancer after platinum therapy. (Abstract #TPS8587)
Poster board: #189b. Sunday, June 3. 8:00 a.m to 11:30. Hall A.
Lead author: Anna F. Farago, MD, PhD. Massachusetts General Hospital

• Phase I trial of lurbinectedin (PM1183) in Japanese patients with advanced tumors: results of the dose escalation part. (Abstract
#2551)
Poster board: #377. Monday, June 4. 8:00 a.m. to 11:30. Hall A
Lead author: Shunji Takahashi, MD. Cancer Institute Hospital of JFCR
Yondelis (trabectedin)
Trabectedin is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair.

• Whole exome sequencing (WES) od metastatic leiomyosarcoma (LMS) and liposarcoma (LPS) and correlation of genomic aberrations
with clinical outcomes in the phase III randomized trial of trabectedin (T) vs. dacarbazine (D). (Abstract #11513)
Poster board: #258. Saturday, June 2. 15:00 to 16:15. Hall A
Lead author: Gurpreet Kapoor. Scientific Operations, LabConnect LLC.

• Multi-institutional European phase I/II trial of trabectedin plus radiotherapy in metastatic soft tissue sarcoma (STS) patients. A Collaborative Spanish (GEIS), Italian (ISG) and French (FSG)
Sarcoma Groups study. (Abstract #11544)
Poster board: #289. Saturday, June 2. 15:00 to 16:15. Hall A
Lead author: Javier Martin Broto MD, PhD. Hospital Universitario Virgen del Rocio, Instituto de Investigación Biomédica, Universidad de Sevilla, Spain.

• Impact of pathological stratification of advanced well differentiated/dedifferentiated (WD/DD) liposarcoma (LPS) on theresponse to trabectedin (T). (Abstract #11566)
Poster board: #311. Saturday, June 2. 15:00 to 16:15. Hall A
Lead author: Roberta Sanfilippo, MD. Departamento de Oncología Médica, Fondazione IRCCS Istituto Nazionale dei Tumori

• Phase 1/2 study of safety/efficacy using trabectedin, ipilimumab and nivolumab triple therapy as first line of treatment of advanced soft tissue sarcoma. (Abstract #TPS11591)
Poster board: #333b. Saturday, June 2. 15:00 to 16:15. Hall A

Lead author: Erlinda Maria Gordon, MD. Sarcoma Oncology Center
• Results of a prospective randomized phase III T-SAR trial comparing trabectedin (T) vs best supportive care (BSC) in patients with pretreated advanced soft tissue sarcoma (ASTS): A French Sarcoma
Group (FSG) trial. (Abstract #11508)
Oral sesión. Monday, June 4. 8:00 a.m. to 11:00. S100a
Lead author: Axel Le Cesne, MD. Gustave Roussy Cancer Campus Plitidepsin

• Overall survival (OS) results of randomized phase III study (ADMYRE trial) of plitidepsin and dexamethasone (DXM) vs. DXM alone in patients with relapsed/refractory multiple myeloma (RRMM): Evaluation of the crossover impact. (Abstract #8018)
Poster board: #27. Monday, June 4. 8:00 to 11:30. Hall A
Discussed ta the poster discussion session on Monday, June 4, 15:00 to
16:15 at E450
Lead autor: Javier Gómez, PharmaMar

About YONDELIS (trabectedin)
YONDELIS (trabectedin) is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in close 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL/CAELYX (doxorubicin HCl liposome injection) in the European Union. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.

About lurbinectedin
Lurbinectedin is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

On May 17, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that one abstract on Genmab’s DuoBody-CD3xCD20 and six industry sponsored abstracts on daratumumab will be presented at the 23rd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress 2018 in Stockholm, Sweden, June 14-17 (Press release, Genmab, MAY 17, 2018, View Source [SID1234526767]). An abstract containing a pre-clinical evaluation of Genmab’s proprietary DuoBody-CD3xCD20 will be presented as a poster. The daratumumab abstracts, submitted by Janssen Research & Development, LLC, include an oral presentation on ALCYONE (MMY3007), the Phase III trial of daratumumab plus bortezomib, melphalan and prednisone in newly diagnosed multiple myeloma that was the basis for the recent U.S. Food and Drug Administration approval. There will also be an oral presentation regarding the Phase II CENTAURUS (SMM2001) study of daratumumab in smoldering multiple myeloma. The abstracts have been published on the EHA (Free EHA Whitepaper) website, and may be accessed via www.ehaweb.org.

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"In addition to the multiple presentations of daratumumab clinical data in multiple myeloma or amyloidosis, we are very pleased that a pre-clinical evaluation of our proprietary DuoBody-CD3xCD20 product will be presented to the attendees at this year’s EHA (Free EHA Whitepaper) congress," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

List of Industry Sponsored Abstracts

DuoBody-CD3xCD20
CD3 Bispecific Antibody Screen Identifies CD20 as the Most Efficient Target for Elimination of B Cell Malignancies; Pre-clinical Evaluation of DuoBody-CD3xCD20 — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

Daratumumab
Daratumumab Plus Bortezomib-Melphalan-Prednisone (VMP) in Elderly (≥75 Years of age) Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplantation (ALCYONE) — Oral presentation, Friday, June 15, 12:00 PM — 12:15 PM CEST

Effects of Daratumumab on the Composition and Activation Status of Immune-Cell Populations in CENTAURUS, a Phase 2 Randomized Study of Smoldering Multiple Myeloma (SMM) Patients — Oral presentation, Sunday, June 17, 8:30 AM — 8:45 AM CEST

Subcutaneous Daratumumab (DARA SC) + Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis: Safety Run-in Results of ANDROMEDA — Poster presentation, Saturday, June 16, 5:30 PM — 7:00 PM CEST

Daratumumab, Carfilzomib and Dexamethasone (D-Kd) in Lenalidomide-refractory Patients with Relapsed Multiple Myeloma (MM): Subgroup Analysis of MMY1001 — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Update of the Open-label, Multicenter, Dose Escalation Phase 1b Study (PAVO) — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

Impact of Baseline Renal Function on Efficacy and Safety of Daratumumab Plus Bortezomib-Melphalan-Prednisone (VMP) in Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplantation (ALCYONE) — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

On May 17, 2018 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective cancer medicines, reported that it will present Phase 1 results from a Phase 1/2a study of PEN-221 in patients with neuroendocrine tumors or small cell lung cancer at the 2018 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting occurring June 1-5, 2018 in Chicago IL (Press release, Tarveda Therapeutics, MAY 17, 2018, View Source [SID1234526784]).

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The data presented will describe the safety, tolerability, pharmacokinetics, and preliminary efficacy of PEN-221, a miniature drug conjugate containing a peptide ligand that is highly selective in targeting the somatostatin receptor 2 (SSTR2) that is conjugated to the potent payload DM1. SSTR2 is a cell surface target that is overexpressed in a variety of solid tumor cancers. PEN-221 is currently being evaluated in a Phase 2a trial in patients with gastrointestinal midgut neuroendocrine tumors, pancreatic neuroendocrine tumors, or small cell lung cancer.

"We are very pleased to have completed the Phase 1 portion of our Phase 1/2a clinical trial for PEN-221 on schedule and to present the data from the Phase 1 trial evaluating PEN-221 at ASCO (Free ASCO Whitepaper)," said Drew Fromkin, President and Chief Executive Officer of Tarveda. "We are encouraged by the data from studies of PEN-221 to date and look forward to advancing the Phase 2a portion of the study for PEN-221 as well as our Phase 1 trial for PEN-866."

Details of the poster presentation are as follows:

Title: First in human phase 1/2a study of PEN-221 somatostatin analog (SSA)-DM1 conjugate for patients (PTS) with advanced neuroendocrine tumor (NET) or small cell lung cancer (SCLC): Phase 1 results.
Abstract Number: 4097
Date: June 3, 2018
Time: 8:00 – 11:30 AM CT
Location: Hall A

About Pentarins
Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell killing payload inside the cancer cells for efficacy.