On October 4, 2018 Pfizer Inc. reported the recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards (Press release, Pfizer, OCT 4, 2018, View Source [SID1234529942]). Four grants totaling more than $3 million (USD) in funding will be awarded to investigators in the United States (U.S.) to support clinical research projects involving Pfizer compounds in breast cancer. Since 2015, Pfizer has provided more than $16 million in total funding for the ASPIRE Oncology Research Awards Program across breast and hematologic cancers.

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"The ASPIRE awards underscore Pfizer’s commitment to collaborating with investigators to expand scientific knowledge and improve the treatment of breast cancer," said Lynn McRoy, M.D., breast cancer lead, U.S. Medical Affairs, Pfizer Oncology. "The recipients of the 2018 awards submitted outstanding clinical research proposals that have the potential to advance care for people living with breast cancer."

Recipients of the 2018 awards were selected through a competitive application process overseen by an independent review panel of experts. The following investigators and studies have been selected to receive grants:

Dr. Mylin A. Torres, Glenn Family Breast Center, Winship Cancer Institute, Emory University – A Phase 2 Multi-institutional Study of Concurrent Radiotherapy, Palbociclib, and Hormone Therapy for Treatment of Bone Metastasis in Breast Cancer Patients
Dr. Aditya Bardia, Massachusetts General Hospital Cancer Center – Evaluation of Talazoparib, a PARP Inhibitor, for Patients With Somatic BRCA Mutant Metastatic Breast Cancer in a Genotyping Based Clinical Trial
Dr. Antoinette Tan, Levine Cancer Institute, Atrium Health – IGNITE-Immunoprofiling of Gedatolisib, a Dual PI3-Kinase and mTOR Inhibitor, in the Neo-Immunoadjuvant Treatment of Early Stage Breast Cancer
Dr. Kari Wisinski, University of Wisconsin Carbone Cancer Center – Phase 2 Trial with Safety Run-In of Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1 or 2 Positive, HER2 Negative Breast Cancers
Investigators in the U.S. were encouraged to submit proposals for the 2018 ASPIRE Breast Cancer Research Awards that advance knowledge in the treatment and disease management of breast cancer. Proposals were eligible for IBRANCE (palbociclib), an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6, for metastatic breast cancer, the most advanced stage of breast cancer (stage IV)1,2; talazoparib, an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor; and gedatolisib (PF-05212384), an investigational, small molecule, dual inhibitor targeting the phosphatidylinositol-3-kinase (PI3K) and mammalian target of rapamycin (mTOR) signaling pathways in the development of solid tumors.

For more information about ASPIRE, please visit www.aspireresearch.org.

About IBRANCE (palbociclib) 125 mg capsules
IBRANCE is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase
inhibitor as initial endocrine based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine
therapy.

IMPORTANT IBRANCE (palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

Neutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever.

Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of first 2 cycles and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants.

The most common adverse reactions (≥10%) of any grade reported in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase (43% vs 30%).

The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%).

Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.

For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis.

On October 3, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that four posters featuring data and highlighting studies from the Rubraca clinical development program will be presented at the ESMO (Free ESMO Whitepaper) 2018 Congress (European Society for Medical Oncology), 19-23 October, 2018, in Munich, Germany (Press release, Clovis Oncology, OCT 3, 2018, View Source [SID1234529725]). These posters include the first presentation of initial results from the Phase 2 TRITON2 clinical trial of Rubraca, an oral, small molecule PARP inhibitor, in advanced mCRPC, as well as genomic profiling data based on tumor tissue and plasma cfDNA samples from patients who were screened following progression on prior therapy for enrollment in TRITON2 or the Phase 3 TRITON3 clinical study. Both datasets from the TRITON clinical program have been selected for inclusion in a poster discussion session that will be led by invited discussant Dr. Joaquin Mateo, of the Prostate Cancer Translational Research Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain.

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"We look forward to presenting a first look at the TRITON2 prostate cancer data at ESMO (Free ESMO Whitepaper), with a primary focus on the BRCA mutant population"

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TRITON2 is an international, multicenter, open-label, Phase 2 study of Rubraca in men with advanced prostate cancer with BRCA gene mutations (germline or somatic) or other deleterious mutations in other homologous recombination (HR) repair genes in the metastatic castration-resistant setting. The study is currently recruiting at approximately 100 sites worldwide. On October 2, 2018, Clovis announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation for Rubraca for the treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy. The FDA granted this designation based on the initial efficacy and safety results from TRITON2 that will be shared at the ESMO (Free ESMO Whitepaper) 2018 Congress.

"We look forward to presenting a first look at the TRITON2 prostate cancer data at ESMO (Free ESMO Whitepaper), with a primary focus on the BRCA mutant population," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The data and updates we will share at ESMO (Free ESMO Whitepaper) emphasize our commitment to developing Rubraca beyond its initial ovarian cancer indications."

The four Rubraca abstracts from Clovis Oncology that have been accepted for poster presentation at the ESMO (Free ESMO Whitepaper) 2018 Congress are:

Title: ARIEL3: Subgroup analysis of rucaparib in platinum-sensitive recurrent ovarian carcinoma: effect of prior chemotherapy regimens (abstract 947P)
Presenter: Dr. Domenica Lorusso, Unità di Ginecologia Oncologica, Fondazione IRCCS Istituto Nazionale dei Tumori and MITO, Milan, Italy
Session: Poster session
Date/Time: Saturday, 20 October, 12:30–13:30 CEST
Location: Hall A3

Title: Preliminary results from TRITON2: a phase 2 study of rucaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination repair (HRR) gene alterations (abstract 793PD)
Presenter: Dr. Wassim Abida, Memorial Sloan Kettering Cancer Center, New York, NY, USA
Session: Poster discussion session, genitourinary tumors, prostate
Date/Time: Sunday, 21 October, 09:15–10:30 CEST
Location: Room 14b
As the subject of a poster discussion session, this poster will be on display for the duration of the congress beginning at 9:00 CEST on Saturday, 20 October 2018.

Title: TRITON: Genomic profiling of circulating tumour DNA (ctDNA) and tumour tissue for the evaluation of rucaparib in metastatic castration-resistant prostate cancer (mCRPC) (abstract 795PD)
Presenter: Dr. Simon Chowdhury, Guy’s Hospital & Sarah Cannon Research Institute, London, UK
Session: Poster discussion session, genitourinary tumours, prostate
Date/Time: Sunday, 21 October, 09:15–10:30 CEST
Location: Room 14b
As the subject of a poster discussion session, this poster will be on display for the duration of the congress beginning at 9:00 CEST on Saturday, 20 October 2018.

Title: ATLAS: a phase 2, open-label study of rucaparib in patients with locally advanced (unresectable) or metastatic urothelial carcinoma (abstract 928TIP)
Presenter: Dr. Simon Chowdhury, Guy’s Hospital & Sarah Cannon Research Institute, London, UK
Session: Poster session
Date/Time: Monday, 22 October, 13:15–14:15 CEST
Location: Hall A3

Specific program times and locations are subject to change by ESMO (Free ESMO Whitepaper).

Clovis’ Rubraca poster presentations will be available online at clovisoncology.com at 07:30 CEST on Saturday, 20 October, 2018.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and Europe.

Rubraca EU Authorized Use

Rubraca is licensed for 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.

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

Rubraca U.S. FDA Approved Indications and Important Safety Information

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, 5 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.

On October 3, 2018 Harpoon Therapeutics, Inc., a clinical-stage immunotherapy company developing a new class of T cell engaging therapeutics, reported that it has appointed Natalie R. Sacks, M.D., as Chief Medical Officer (Press release, Harpoon Therapeutics, OCT 3, 2018, View Source [SID1234529726]).

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"We are thrilled to welcome Dr. Sacks as our new Chief Medical Offer. Natalie brings a strong record of accomplishment in the development and commercialization of oncology therapeutics, which will be instrumental as we advance our pipeline in the clinic," said Jerry McMahon, Ph.D., President and Chief Executive Officer, Harpoon.

"As an oncologist, I look forward to joining a company that is pioneering new ways to treat cancer and impact the lives of patients in need," says Dr. Sacks. "I am excited about the potential of Harpoon’s clinical programs and its novel TriTAC platform to redirect a patient’s own T cells to attack tumor cells."

Dr. Sacks most recently served as Chief Medical Officer of Aduro Biotech, a company focused on the advancement of novel immuno-oncology technologies. Previously, she was Vice President of Clinical Development at Onyx Pharmaceuticals (acquired by Amgen) where she played a key role in the development and approval of Kyprolis, an FDA-approved therapy for the treatment of multiple myeloma, and in business development strategy. Prior to that, she served as Vice President of Clinical Research for Exelixis where she directed the development of a portfolio of small molecules, with responsibilities ranging from IND filings to late-stage development, including development of Cometriq. Earlier in her career, Dr. Sacks served as Vice President of Clinical Development at Cell Genesys, a company focused on the development of cancer vaccines and engineered chimeric antigen receptor (CAR)-T cells. She received her M.D. from the University of Pennsylvania School of Medicine, her M.S. in Biostatistics from the Harvard University T.H. Chan School of Public Health and her B.A. in Mathematics from Bryn Mawr College. Dr. Sacks was an Assistant Clinical Professor at the University of California, San Francisco, and served as volunteer Attending Physician in Hematology-Oncology at San Francisco General Hospital for more than a decade. She serves as a board member for Zymeworks Inc. and Caribou Biosciences.

On October 3, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will announce its financial results for the third quarter of 2018 on Tuesday, November 6, 2018 (Press release, Eli Lilly, OCT 3, 2018, View Source [SID1234529747]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On October 3, 2018 ArcherDX, a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine and Merck KGaA, Darmstadt, Germany, the vibrant science and technology company which operates its biopharmaceuticals business in the U.S. and Canada as EMD Serono, reported that they have entered into an agreement to develop and commercialize a next generation sequencing (NGS)-based companion diagnostic (CDx) assay (Press release, ArcherDX, OCT 3, 2018, View Source,-darmstadt,-germany-selects-archerdx-for-strategic-global-companion-diagnostic-assay-development-collaboration [SID1234529767]).

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Under the terms of the agreement, ArcherDX will develop and seek regulatory approval for a CDx assay that will help physicians identify patients who may benefit from treatment with a Merck KGaA, Darmstadt, Germany drug candidate, by focusing on the detection of specific genomic alterations in plasma or formalin-fixed paraffin-embedded (FFPE) tissue samples. ArcherDX will develop the CDx using the Archer diagnostic platform, which combines the patented Anchored Multiplex PCR (AMP) technology with the Illumina MiSeqDx sequencing system and Archer Analysis bioinformatics software. The CDx assay will be designed to detect multiple classes of genomic alterations across a range of genes implicated in solid malignant neoplasms and is compatible with both FFPE tissue and plasma specimen types.

"We are pleased to launch this strategic companion diagnostic initiative," stated Jason Myers, Ph.D., president and chief executive officer for ArcherDX. "The work we’ve engaged in with Merck KGaA, Darmstadt, Germany highlights the importance and potential of utilizing our proprietary profiling approach to make available to physicians an FDA-approved companion diagnostic solution for use with targeted therapies."