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TECENTRIQ GO29695 (NCT02431208) and BO29562 (NCT02631577) FDA partial clinical hold lifted

On December 5, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY): reported that following close consultation and agreement on study modifications with the U.S. Food and Drug Administration (FDA), the partial clinical holds placed on the Phase Ib and Phase Ib/II studies evaluating TECENTRIQ in combination with an immunomodulatory medicine (IMiD) in relapsed/refractory multiple myeloma and relapsed/refractory follicular lymphoma have been lifted (Press release, Hoffmann-La Roche, DEC 5, 2017, View Source [SID1234522368]). The studies will continue in accordance with the protocol amendments agreed upon by the FDA.

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The studies had been placed on partial clinical hold as part of an FDA evaluation of all ongoing blood cancer trials, investigating PD-1/PD-L1 inhibitors in combination with an IMiD to determine if there was a class-wide (PD-1/PD-L1 inhibitor) concern in multiple myeloma/blood cancers, or a specific concern with certain combinations with IMiDs. The FDA evaluation was prompted by interim data from clinical trials evaluating pembrolizumab in combination with either lenalidomide or pomalidomide in multiple myeloma.

Acceleron to Host Conference Call and Webcast to Review Data Presented at the 59th American Society of Hematology Annual Meeting and Exposition

On December 5, 2017 Acceleron Pharma Inc. (NASDAQ:XLRN) reported that it will host a conference call and live audio webcast on Monday, December 11, 2017 at 7:00 a.m. EST to review highlights from its Phase 2 clinical presentations at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 9-12, 2017 in Atlanta, Georgia (Press release, Acceleron Pharma, DEC 5, 2017, View Source [SID1234522377]).

Participants can access the live conference call by dialing 877-312-5848 (domestic) or 253-237-1155 (international) and referring to the Acceleron ASH (Free ASH Whitepaper) 2017 update.

The live webcast can be accessed on the Investors page of the company’s website at www.acceleronpharma.com.

A replay of the webcast will be available approximately two hours after the event on the Acceleron website.

BioLineRx Ltd. Hosts Investor Breakfast Meeting in NY

On December 5, 2017 BioLineRx Ltd. (NASDAQ/TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that on this date it hosts its investor breakfast meeting at the Convene Conference Center near Grand Central in New York, NY (Press release, BioLineRx, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321125 [SID1234522378]).

Philip Serlin, Chief Executive Officer of BioLineRx, stated, "This annual event gives us the opportunity to directly meet with our investors for updates on our progress: steady advancements on our multiple clinical programs in stem cell mobilization, combination immunotherapies and acute myeloid leukemia (AML), as well as our new and novel immuno-oncology therapy. And we are pleased to feature a presentation by Dr. John DiPersio, Chief, Division of Oncology at Washington University School of Medicine, an internationally-renowned hematologist and expert on the role of CXCR4 in stem-cell mobilization and hematological malignancies. There remains a large, unmet need for cancer therapies and we remain focused on advancing programs that improve upon current treatments and the standard of care."

In addition to the keynote presentation by Dr. DiPersio on bone marrow transplantation and the role of CXCR4 in cancer, additional topics for discussion at the ongoing BioLineRx investor breakfast meeting include: (i) presentation on BL-8040 clinical development plans in immuno-oncology combinations and AML, as well as on the upcoming GENESIS Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation in multiple myeloma patients; (ii) presentation of AGI-134, the Company’s novel immuno-oncology project; and (iii) an overview of the Company’s plans and expected milestones for 2018.

BioLineRx is hosting a live webcast of the investor breakfast today between 9:00-10:30 am ET. To access the webcast, please go to the breakfast event page on BioLineRx’s website. An audio replay of the meeting will also be available for approximately three months following the meeting on the breakfast event page.

CORPORATE PRESENTATION

On December 5, 2017 BioLineRx presented Corporate Presentation (Presentation, BioLineRx, DEC 5, 2017, View Source [SID1234522388]).

Adaptimmune Data to be Presented at American Society of Hematology (ASH) Annual Meeting Confirm NY-ESO SPEAR T-cell Efficacy in Multiple Myeloma Pilot Study

On December 5, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will update data from its completed pilot study1 of NY‑ESO SPEAR T-cell therapy in multiple myeloma patients in the setting of autologous stem cell transplant (ASCT) presented at the annual ASH (Free ASH Whitepaper) meeting at the Georgia World Congress Center in Atlanta, Ga (Press release, Adaptimmune, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321280 [SID1234522387]).

During an oral presentation, Dr. Edward Stadtmauer, University of Pennsylvania Abramson Cancer Center, will present an update on all twenty-five multiple myeloma patients treated in Adaptimmune’s pilot study in the setting of ASCT. The data cut-off for the abstract was through July 2017, the data cut-off for the oral presentation was August 16, 2017.

Oral Presentation 845: Phase I/IIa Study of Genetically Engineered NY-ESO-1 SPEAR T-Cells Administered Following Autologous Stem Cell Transplant in HLA-a*02+ Patients with Advanced Multiple Myeloma: Long Term Follow‑up (NCT01352286)

Session: 703. Adoptive Immunotherapy: Gene Engineered T cells for Hematologic Malignancies

Time: Monday, December 11, 2017: 5:30 PM (EST)

Location: Bldg. B, Level 2, B206 (Georgia World Congress Center)

Result highlights from the abstract include:

Overall response rate (ORR) at day 100 was 76% (1 stringent complete response [sCR]; 12 very good partial response [VGPR]; 6 partial response [PR])
At year 1, 13 patients were progression free (52%) of which 11 were responders (1 sCR; 1 CR; 8 VGPR; 1 PR)
Three patients remain disease progression-free at 39, 56, and 61 months post T-cell infusion
Median progression free survival (PFS) was ~13 months (range 3-61 months)
Eleven of 25 patients (44%) are alive, and median survival was ~35 months (range 6-68 months)
Autologous GvHD (24%) was reported in 6 patients (3 G3, 3 ≤G2); all resolved with corticosteroids and supportive therapy
No fatal adverse events have been reported