On May 16, 2019 Foundation Medicine, Inc. reported that new data informed by the use of its portfolio of comprehensive genomic profiling (CGP) tests will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 31 to June 4 in Chicago (Press release, Foundation Medicine, MAY 16, 2019, View Source [SID1234536409]). The company and its collaborators will present a total of 18 studies, including two poster discussions.

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Highlights of these presentations include:

New data that provides additional insights into the utility of tumor mutational burden (TMB) as a pan-tumor genomic biomarker across a variety of cancers, including metastatic breast cancer and non-small cell lung cancer (NSCLC), and how it impacts response to immunotherapy;
Studies demonstrating the utility of known and novel biomarkers, including results in cancers that have not traditionally been treated with targeted therapies, such as urothelial cancer and cholangiocarcinoma; and
Results from analysis of data within Foundation Medicine and Flatiron Health’s clinico-genomic database demonstrating that combining measures of TMB and PD-L1 can better predict response to immunotherapy in advanced NSCLC patients than either biomarker alone.
Data to be presented support the clinical use of tissue and liquid CGP tests and demonstrate the importance of genomic biomarkers to help inform selection of targeted therapies, including immunotherapies, across a variety of advanced tumor types.

"We are excited to share new data derived from the use of comprehensive genomic profiling to further characterize the molecular underpinnings of cancer and provide additional evidence of the role of biomarkers in optimizing precision medicine approaches," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "Given the continued pace of innovation for targeted and immunotherapies, the clinically relevant insights derived from comprehensive genomic profiling, including those from Foundation Medicine and Flatiron Health’s unique database of clinico-genomic information, are a vital source of information to support the development of such therapies and can help improve clinical decision-making and patient care."

Tumor Mutational Burden (TMB) as Predictor of Response to Immunotherapy

In one study, more than 3,800 metastatic breast cancer samples were classified as HER2 negative (ER+/HER2-), HER2 amplified and triple negative breast cancer. The study showed that TMB can help predict responsiveness to immunotherapy, which has been difficult to show in metastatic breast cancer patients, across all three subtypes.

[Immunotherapy predictive biomarkers in metastatic breast cancer (MBC). Poster discussion. Abstract 1023, Poster #104. June 2, 8:00am – 11:00am, Hall A. Poster Discussion – June 2, 11:15am – 12:45pm, Hall D2.]

Another study to be presented by Friends of Cancer Research found it is feasible to standardize the measurement of TMB across different CGP testing platforms, including FoundationOneCDx. These data were drawn from the findings of the organization’s TMB Harmonization Project, which aims to establish best practices to improve consistency and reliability of TMB estimation across platforms in the interest of optimizing the clinical utility of TMB in cancer care through engaging a coalition of research and industry organizations, including Foundation Medicine.

[TMB standardization by alignment to reference standards: Phase II of the Friends of Cancer Research TMB Harmonization Project. Abstract 2624, Poster #268. June 1, 8:00am – 11:00am, Hall A. Presented by Friends of Cancer Research.]

Utility of Comprehensive Genomic Profiling

In a retrospective analysis, more than 200,000 relapsed or refractory cancers were evaluated to determine how pan-tumor FGFR2 genomic alterations co-occur with other genomic alterations including TMB, microsatellite instability (MSI), and PD-L1 expression. Cancers with an FGFR2 receptor tyrosine kinase (RTK) alteration were shown to have higher frequency of elevated TMB than cancers with other RTK alterations, suggesting potential immunotherapy responsiveness.

[FGFR2: A pan-genomic target. Abstract 3099, Poster #91. June 1, 8:00am – 11:00am, Hall A.]

In another retrospective analysis, researchers evaluated more than 2,000 primary and metastatic urothelial cancer cases, the largest analysis of its kind. All classes of genomic alterations were evaluated in two subtypes of the cancer: upper tract and bladder tumors. FGFR3 was found more frequently in upper tract tumors (26 percent of cases) than in bladder tumors (19 percent of cases). Overall, 48 percent of all tumors harbored genomic alterations that could benefit from approved or investigational targeted therapies, suggesting CGP should be incorporated into routine evaluation of metastatic urothelial cancer before initiating treatment.

[Comprehensive genomic profiling (CGP) of upper-tract (UTUC) and bladder (BUC) urothelial carcinoma reveals opportunities for therapeutic and biomarker development. Abstract 4581, Poster #346. June 3, 1:15pm – 4:15pm, Hall A. Poster Discussion – June 3, 4:30pm – 6:00pm, Hall D2.]

A study characterizing NSCLC cases found HER2 exon 20 insertion mutations in 1.5 percent (n=648) of NSCLC cases analyzed and noted that these are generally mutually exclusive of other known drivers. Detection of these alterations using tissue or liquid CGP may be critical to identify matched targeted therapy options, which have recently shown efficacy in the clinic, for this subset of patients.

[Characterization of 648 non-small cell lung cancer (NSCLC) cases with 28 unique HER2 exon 20 insertions. Abstract 9063. Poster #386. June 2, 8:00am – 11:00am, Hall A.]

Using Data to Advance Precision Medicine

Another ASCO (Free ASCO Whitepaper) presentation will share data from a clinico-genomic database, which includes more than 50,000 de-identified matched profiles linking comprehensive genomic profiling results from Foundation Medicine with patient outcomes data from Flatiron Health’s electronic health records database. The study evaluated more than 400 advanced NSCLC patients and showed that combining the biomarkers TMB and PD-L1 expression can predict response to immunotherapy better than either of these markers alone, reinforcing the importance of testing patients for both biomarkers to inform treatment strategies.

[Tumor mutational burden (TMB) and PD-L1 expression as predictors of response to immunotherapy (IO) in NSCLC. Abstract 2630, Poster #274. June 1, 8:00am – 11:00am, Hall A. Presented by Flatiron Health.]

The following is a list of select abstracts that will be presented at the meeting. For a full list of the data being presented by Foundation Medicine and its collaborators, please visit: View Source

Abstract #

Title

Collaborator

Day/Time

Location

Foundation Medicine Poster Discussions

1023

Immunotherapy predictive biomarkers in metastatic breast cancer (MBC).

June 2: Poster Display –8:00 – 11:00am

Poster Discussion – 11:15am –12:45pm

Hall A

Hall D2

4581

Comprehensive genomic profiling (CGP) of upper-tract (UTUC) and bladder (BUC) urothelial carcinoma reveals opportunities for therapeutic and biomarker development.

June 3:

Poster Display – 1:15pm –4:15pm

Poster Discussion – 4:30pm –6:00pm

Hall A

Hall D2

Foundation Medicine Posters

3099

FGFR2: A pan-genomic target.

June 1, 8:00am – 11:00am

Hall A

6557

Accelerating advanced precision medicine through a harmonized data exchange platform and research consortium (PMEC).

June 1, 1:15pm – 4:15pm

Hall A

9063

Characterization of 648 non-small cell lung cancer (NSCLC) cases with 28 unique HER2 exon 20 insertions.

June 2, 8:00am – 11:00am

Hall A

3533

RAS-amplified colorectal cancers: Microsatellite stability status, RAS/BRAF mutations, and prediction of anti-EGFR resistance.

June 3, 8:00am – 11:00am

Hall A

4545

Analysis of EGFR mutant urothelial carcinoma (UC) reveals distinct mutational landscape.

June 3, 1:15pm – 4:15pm

Hall A

9566

Anal melanoma: A comparative comprehensive genomic profiling study.

June 3, 1:15pm – 4:15pm

Hall A

9591

Extra-mammary Paget’s disease (EMPD) of the skin: A comprehensive genomic profiling (CGP) study.

June 3, 1:15pm – 4:15pm

Hall A

Foundation Medicine and Collaborator Presentations

2630

Tumor mutational burden (TMB) and PD-L1 expression as predictors of response to immunotherapy (IO) in NSCLC.

Flatiron Health

June 1, 8:00am – 11:00am

Hall A

2624

TMB standardization by alignment to reference standards: Phase II of the Friends of Cancer Research TMB Harmonization Project.

Friends of Cancer Research

June 1, 8:00am – 11:00am

Hall A

4080

Comprehensive genomic profiling in FIGHT-202 reveals the landscape of actionable alterations in advanced cholangiocarcinoma.

Incyte

June 3, 8:00am – 11:00am

Hall A

4087

Profiling of 3,634 cholangiocarcinomas (CCA) to identify genomic alterations (GA), tumor mutational burden (TMB) and genomic loss of heterozygosity (gLOH).

MD Anderson

June 3, 8:00am – 11:00am

Hall A

4535

Squamous-cell carcinoma variant histology (SCC-VH) in muscle-invasive bladder cancer (MIBC): A comprehensive clinical, genomic, and therapeutic assessment from multiple dataset.

Fondazione IRCCS Istituto Nazionale dei Tumori

June 3, 1:15pm – 4:15pm

Hall A

On May 16, 2019 Eli Lilly and Company (NYSE:LLY) reported that it will attend the UBS Global Healthcare Conference on Tuesday, May 21, 2019 (Press release, Eli Lilly, MAY 16, 2019, View Source [SID1234536408]). Christi Shaw, president of Lilly Bio-Medicines, will participate in a fireside chat at 9:30 a.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On May 16, 2019 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST) reported that two abstracts relating to the MANIFEST clinical trial of CPI-0610 for myelofibrosis – one in association with the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and the other in association with the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting – published online (Press release, Constellation Pharmaceuticals, MAY 16, 2019, View Source [SID1234536407]). The abstracts include an analysis based on a data cutoff of January 17, 2019, from 18 enrolled patients. Upcoming presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) will reflect an analysis of a larger patient population based on a data cutoff of April 17, 2019.

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MANIFEST is an open-label Phase 2 clinical trial of CPI-0610 in patients with myelofibrosis (MF), a rare cancer of the bone marrow that disrupts the body’s normal production of blood cells. Constellation is evaluating CPI-0610, either as a monotherapy or in combination with ruxolitinib, in a second-line setting in patients with MF who are refractory to or intolerant of or have relapsed or lost response to ruxolitinib. Patients in the two second-line arms are being stratified based on transfusion dependent status. The primary endpoint for the cohorts with transfusion-dependent patients is conversion to transfusion independence for 12 consecutive weeks. The primary endpoint for the patients who were non-transfusion dependent at baseline is spleen volume reduction. In addition, the Company added a third arm designed to evaluate treatment with CPI-0610 in combination with ruxolitinib as a first-line therapy in JAK 1/2-inhibitor-naïve MF patients.

Data Highlights From Abstracts

Below are highlights of data on second-line patients in the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) abstracts, which published on May 15 and May 16, respectively.

Spleen volume reductions as measured by MRI occurred in all ten evaluable patients and ranged from 6% to 44%.

Symptom improvements were observed.

Out of the four patients who received bone marrow assessments, three had a one-grade improvement in bone marrow fibrosis and had hemoglobin increases of ≥1.5 g/dL for ≥12 weeks without transfusions. The fourth patient had a one-grade improvement in the bone marrow reticulin score. All of these score improvements were based on a scale of 0-3.

Two of the four patients with bone marrow assessments were transfusion dependent at baseline, and both of these patients became transfusion independent.

Hemoglobin increases of ≥1.5 g/dL occurred in both of two evaluable patients on monotherapy and three of nine patients on the combination with ruxolitinib.

CPI-0610, both as monotherapy and in combination with ruxolitinib, was generally well tolerated. The most common side effects were Grade 1 / 2 diarrhea, nausea / vomiting, and reversible and non-cumulative thrombocytopenia.
"Interim data from the MANIFEST trial indicate that CPI-0610 has been generally well-tolerated, with promising therapeutic activity for the treatment of myelofibrosis," said Adrian Senderowicz, Chief Medical Officer at Constellation Pharmaceuticals. "In addition to spleen and symptom improvement in these refractory patients, we are pleased to see an array of clinical data suggesting the potential for disease-modifying effects, such as improved hematopoietic function, conversion to transfusion independence, and improvement in bone marrow fibrosis. We look forward to providing further updates of the MANIFEST trial at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper)."

ASCO Poster Presentation

TITLE: A Phase 2 Study of CPI-0610, a Bromodomain and Extraterminal Protein Inhibitor (BETi) alone or with Ruxolitinib (RUX), in Patients with Myelofibrosis (MF)

Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date and Time: Monday, June 3, 2019, 8:00 AM CDT (9:00 AM EDT)

Dr. Marina Kremyanskaya of the Mount Sinai School of Medicine, an investigator in the MANIFEST clinical trial, will present a poster with updated details of interim data at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The data to be presented in the poster were gathered from 44 patients enrolled as of April 17, 2019. Twelve patients received 24-week assessments and 16 patients received 12-week assessments. Among the parameters being assessed were spleen volume reduction, total symptom scores, transfusion dependence, bone marrow fibrosis, and safety.

EHA Oral Presentation

TITLE: CPI-0610, A Bromodomain and Extraterminal Domain (BET) Inhibitor, Reduces Proinflammatory Cytokines, Bone Marrow Fibrosis and the Number of Transfusions in Myelofibrosis Patients

Session: New Agents in MPN

Date and Time: June 15, 12:15 PM CEST (6:15 AM EDT)

Dr. Ronald Hoffman of Mt. Sinai Health System, an investigator in MANIFEST, will make an oral presentation on these updated interim data at the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting on June 15 at 12:15 PM CEST.

Investor Event. Constellation will also host an investor meeting and conference call to discuss these interim data on June 4 at 7:00 AM CDT. This event will include participation by Dr. Srdan Verstovsek, a medical oncologist at the University of Texas MD Anderson Cancer Center who is an investigator in the MANIFEST trial, and Dr. Raajit Rampal, hematologic oncologist at Memorial Sloan Kettering Cancer Center. Details will be announced later.

On May 16, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that four abstracts featuring data for Rubraca (rucaparib) and ongoing studies in multiple tumor types will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 – June 4 in Chicago (Press release, Clovis Oncology, MAY 16, 2019, View Source [SID1234536406]).

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The accepted abstracts summarize clinical trials in which Rubraca is being evaluated as a single agent and as combination therapy with nivolumab in a variety of solid tumor types including ovarian, prostate, biliary tract and endometrial cancers. These include additional genomic profiling data from TRITON2, and new data from extended follow up of patients in ARIEL3.

"Increased understanding about the role of genomic mutations, as well as the growing number and type of oncology therapies, offer tremendous potential for us to more precisely target and improve treatment of the most challenging cancers," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "In our own clinical development program and in investigator-led studies, we are evaluating the utility of Rubraca in multiple solid tumor types where there is genomic rationale, including among patients with BRCA1/2 mutations as well as mutations in other genes that play a role in DNA repair."

The two Clovis Oncology-sponsored abstracts accepted for presentation at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting comprise:

Abstract 5031 (Poster Board #143) – Genomic characteristics of deleterious BRCA1 and BRCA2 alterations and associations with baseline clinical factors in patients with metastatic castration-resistant prostate cancer enrolled in TRITON2

Presenter: Wassim Abida, MD, PhD
Session: Genitourinary (Prostate) Cancer
Date/Time: Saturday, June 1, 1:15-4:15 p.m. Central Daylight Time (CDT)
Location: Hall A
Abstract 5522 (Poster Board #345) – Exploratory analysis of the effect of maintenance rucaparib on post-progression outcomes in patients with platinum-sensitive recurrent ovarian carcinoma and updated safety data from the phase 3 study ARIEL3

Presenter: Robert L. Coleman, MD, FACOG, FACS
Session: Gynecologic Cancer
Date/Time: Saturday, June 1, 1:15-4:15 p.m. CDT
Location: Hall A
This poster (abstract #5522) will be discussed at the associated poster discussion session on Saturday, June 1, 4:30-6:00 p.m. CDT in Room S406.

The two Clovis-sponsored posters will be available online at View Source once they are presented at the meeting.

Additionally, two investigator-sponsored abstracts describing combination studies of Rubraca and nivolumab trials in progress are also being presented:

Abstract TPS2663 (Poster Board #297b) – A phase Ib/IIa study of rucaparib (PARP inhibitor) combined with nivolumab in metastatic castrate-resistant prostate cancer and advanced/recurrent endometrial cancer

Presenter: Raanan Alter, MD
Session: Developmental Immunotherapy and Tumor Immunobiology
Date/Time: Saturday, June 1, 8:00-11:00 a.m. CDT
Location: Hall A
Abstract TPS4153 (Poster Board #252a) – A multi-center phase II trial of rucaparib in combination with nivolumab as maintenance therapy for patients with advanced biliary tract cancer

Presenter: Vaibhav Sahai, MD
Session: Gastrointestinal (Noncolorectal) Cancer
Date/Time: Monday, June 3, 8:00-11:00 a.m. CDT
Location: Hall A
About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Rubraca U.S. FDA Approved Indications

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutations (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur uncommonly in patients treated with Rubraca, and are potentially fatal adverse reactions. In approximately 1100 treated patients, MDS/AML occurred in 12 patients (1.1%), including those in long-term follow-up. Of these, five occurred during treatment or during the 28-day safety follow-up (0.5%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 28 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA-damaging agents. Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1).

Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose (see Dosage and Administration [2.2] in full Prescribing Information) and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks, or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample cytogenetic analysis. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1–4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%) and neutropenia (20%).

Most common laboratory abnormalities in ARIEL3 (≥ 25%; Grade 1–4) were increase in creatinine (98%), decrease in hemoglobin (88%), increase in cholesterol (84%), increase in alanine aminotransferase (ALT) (73%), increase in aspartate aminotransferase (AST) (61%), decrease in platelets (44%), decrease in leukocytes (44%), decrease in neutrophils (38%), increase in alkaline phosphatase (37%) and decrease in lymphocytes (29%).

Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1–4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%) and thrombocytopenia (21%).

Most common laboratory abnormalities in Study 10 and ARIEL2 (≥ 35%; Grade 1–4) were increase in creatinine (92%), increase in alanine aminotransferase (ALT) (74%), increase in aspartate aminotransferase (AST) (73%), decrease in hemoglobin (67%), decrease in lymphocytes (45%), increase in cholesterol (40%), decrease in platelets (39%) and decrease in absolute neutrophil count (35%).

Co-administration of Rubraca can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring. Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1-844-258-7662.

Click here or full Prescribing Information and additional Important Safety Information.

Rubraca ▼ (rucaparib) EU Authorized Use and Important Safety Information

Rucaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Rucaparib is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Summary warnings and precautions: Haematological toxicity: Patients should not start Rubraca until they have recovered from haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade 1). Complete blood count testing prior to starting treatment with Rubraca and monthly thereafter is advised. Rubraca should be interrupted or dose reduced and blood counts monitored weekly until recovery for the management of low blood counts. Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML): If MDS/AML is suspected, the patient should be referred to a haematologist for further investigation. If MDS/AML is confirmed, Rubraca should be discontinued. Photosensitivity: Patients should avoid spending time in direct sunlight as they may burn more easily. When outdoors, patients should wear protective clothing and sunscreen with SPF of 50 or greater. Gastrointestinal toxicities: Low grade (CTCAE Grade 1 or 2) nausea and vomiting may be managed with dose reduction or interruption. Additionally, antiemetics may be considered for treatment or prophylaxis.

Click here to access the current Summary of Product Characteristics. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

On May 16, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that it has entered into definitive agreements with institutional investors to purchase approximately $5.0 million in a registered direct offering of 1,982,000 common shares and approximately $5.0 million in a concurrent private placement of 2,018,000 common shares (Press release, Cellectar Biosciences, MAY 16, 2019, View Source [SID1234536405]). In conjunction with the offerings the company issued 4,000,000 unregistered warrants to purchase common stock.

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The offerings are expected to result in total gross proceeds of $10.0 million before deducting estimated offering expenses. The company intends to use the net proceeds from the offering for research and development, funding clinical studies, working capital and general corporate purposes. The shares of common stock and warrants were priced at $2.50 per fixed combination. The warrants sold in the private placement will be exercisable immediately, expire five years after the date of issuance, and have an exercise price of $2.40.

Roth Capital Partners served as sole placement agent for the transaction. The offering is expected to close on May 20, 2019, subject to customary closing conditions.

The registered offering described above is being made pursuant to a Registration Statement previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). Copies of the prospectus supplement and accompanying base prospectus relating to the registered offering may be obtained, when available, from Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

The unregistered common shares and warrants were offered pursuant to the exemption from registration afforded by Section 4(a)(2) under the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder. Such common shares, warrants and common shares issuable upon exercise of such warrants have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement registering for resale the unregistered common shares and common shares issuable upon exercise of the warrants within fifteen days of today’s date.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.