On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer (Press release, US FDA, OCT 16, 2018, View Source,advanced%20or%20metastatic%20breast%20cancer [SID1234613394]). Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.

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Approval was based on EMBRACA (NCT01945775), an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.

The primary efficacy outcome was progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by blinded independent central review. Estimated median PFS was 8.6 and 5.6 months in the talazoparib and chemotherapy arms, respectively (HR 0.54; 95% CI: 0.41, 0.71; p<0.0001).

The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity. Most common (≥20%) adverse reactions of any grade were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite.

FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) to identify patients with breast cancer with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib. The effectiveness of the BRACAnalysis CDx test was based on the EMBRACA trial population for whom deleterious or suspected deleterious gBRCAm status was confirmed with either prospective or retrospective testing with BRACAnalysis CDx.

The recommended talazoparib dose is 1 mg taken as a single oral daily dose, with or without food.

View full prescribing information for TALZENNA.

FDA granted this application priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

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Check out recent approvals at the OCE’s podcast, Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.).

On October 16, 2018 Ziopharm Oncology, Inc. (Nasdaq:ZIOP), a biotechnology company focused on development of next generation immunotherapies utilizing gene- and cell-based therapies to treat patients with cancer, reported changes to its Board of Directors and management team (Press release, Ziopharm, OCT 16, 2018, View Source [SID1234530612]). Ziopharm’s Chief Executive Officer Laurence Cooper, M.D., Ph.D, is appointed to the Board of Directors effective immediately, and Francois Lebel, M.D., is stepping down from his position as Chief Medical Officer (CMO) and Executive Vice President of Research & Development, effective Oct. 26.

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"We are pleased to continue the evolution of the Board of Directors with the addition of Dr. Cooper as the Company’s CEO," said Ziopharm’s Lead Director Scott Tarriff, who is Chief Executive Officer of Eagle Pharmaceuticals. "We support Laurence and his plan for the Company’s management team to advance the Controlled IL-12 and Sleeping Beauty platforms."

Ziopharm recently announced it has full developmental control over its technologies and is now evolving its organizational structure. A recruitment process is underway during this transition period aimed at building upon existing expertise to meet the needs of patients and shareholders.

"We are developing and expanding our R&D and clinical development teams to support the Controlled IL-12 and Sleeping Beauty CAR-T and TCR-T programs," said Dr. Cooper. "On behalf of the Board of Directors and management team, I thank Francois for his service to our clinical programs, and we wish him well in his next endeavor."

Dr. Lebel said, "I very much enjoyed working with the team at Ziopharm and the many world-class investigators involved with our trials. I am proud that the team has established a strong data set that supports the potential efficacy of our technologies, including Controlled IL-12 to treat patients with recurrent glioblastoma and likely other solid tumors. As I leave the Company, I believe it is on a solid track for success.

On October 16, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, reported the signing of a work order with leading Contract Research Organization, Theradex Oncology ("Theradex"), detailing the scope to be provided by Theradex for a clinical trial titled, "A Phase 2 Study of a PSA/IL-2/GM-CSF Vaccine for the Treatment of PSA-Recurrent Prostate Cancer in Hormone-Naïve Patients (Press release, Oncbiomune, OCT 16, 2018, View Source [SID1234530471])." The trial, expected to enroll 30 patients, is being hosted At Urology Clinics of North Texas, a ten center 40 physician practice with 12 physicians honored with inclusion in the peer-selected "The Best Doctors in America" list.

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"We’re extremely pleased to have Theradex once again working with us on the further development of ProscaVax," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "Theradex is highly sought after for their experience and expertise in advancing promising cancer therapies and we are fortunate to have them on board to provide oversight and the necessary documentation to move this important trial efficiently forward. We expect to treat our first patient in early December."

OncBioMune has submitted the protocol to the FDA and expects a quick review by the outside IRB. Once approved by the FDA and IRB, the clinical trial information will be submitted to clinicaltrials.gov, with the expectation that the summary of the clinical trial will soon be available for public viewing.

ProscaVax is OncBioMune’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

Per the Phase 2 study protocol, patients to be enrolled will be in "biochemical progression," a disease state with few management options. The goal of treating the recurrent prostate cancer patients with ProscaVax is to inhibit the progression of the disease and prevent or delay treatment with more toxic therapies.

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.

On October 16, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 498 million in the third quarter of 2018 compared to USD 317 million in the third quarter of 2017, an increase of 57% (Press release, Genmab, OCT 16, 2018, View Source [SID1234530344]). The 2018 third quarter net sales were USD 318 million in the U.S. and USD 180 million in the rest of the world.

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Johnson & Johnson reported worldwide operational growth (excluding the impact of foreign currency movements) between the two third quarter periods of 60%.The growth was partially offset by a one-time adjustment outside the U.S. related to accruals for retroactive pricing adjustments which negatively impacted this worldwide operational growth by 16 percentage points.

Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

On October16, 2018 Euronext Paris: FR0010331421 – IPH) reported that updated data from ongoing clinical trials evaluating lead asset, monalizumab, partnered with AstraZeneca/MedImmune, will be presented at the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich, Germany, October 19-23, 2018 (Press release, Innate Pharma, OCT 16, 2018, View Source [SID1234530304]). Eric Vivier, Chief Scientific Officer, is invited to the ESMO (Free ESMO Whitepaper) Congress as speaker in the Early detection of cancer using minimally invasive biomarkers Special Symposium.

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A KOL call will be held Monday, October 22, at 4pm CEST (10 am EDT)

Dial in numbers:

France and International: +33 (0)1 72 72 74 03 US only: +1 646 722 4916

PIN code: 69616804#

The presentation will be made available on the Company’s website 30 minutes before the conference begins.

A replay will be available on Innate Pharma’s website after the conference call.

Posters and presentation details:

Results of a Phase II study evaluating monalizumab in combination with cetuximab in previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
Date and time: October 20, 2018, 15:00
Presentation number: 1049PD
Session: Poster Discussion session – Head and neck
Presenter: Jérôme Fayette, Medical Oncologist at the Centre Léon Bérard Lyon, France
Location: Hall B3 – Room 23, ICM München, Munich, Germany

Title: Translational endpoints in patients with metastatic microsatellite-stable colorectal cancer (MSS-CRC) treated with durvalumab plus monalizumab (anti-NKG2A)
Date & time: October 20, 2018, 12:30
Presentation number: 1194P
Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC – early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Presenter: Jennifer R. Diamond, Associate Professor, Division of Medical Oncology at the Colorado University, Denver, US
Location: Hall A3, Poster Area Networking Hub, ICM München, Munich, Germany

Title: Changes in the innate immune system as early events in cancer
Date & time: October 22, 2018, 15:05 – 15:25
Session: Special Symposium
Session Name: Early detection of cancer using minimally invasive biomarkers
Presenter: Eric Vivier, Chief Scientific Officer of Innate Pharma, Marseille, France
Location: Hall A1 – Room 17, ICM München, Munich, Germany