KITE-585 / Gilead - LARVOL DELTA

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - P2 | N=700 | Enrolling by invitation | Sponsor: Kite, A Gilead Company | Trial completion date: Mar 2041 ➔ Dec 2040 | Trial primary completion date: Mar 2041 ➔ Dec 2040

Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology

The Impact of Prior BCMA Car-T Therapy on the Efficacy BCMA-targeting Bispecifics in Myeloma (YouTube) - "Surbhi Sidana, MD...discusses the sequencing of BCMA-targeting CAR-T cells and bispecific antibodies in relapsed/refractory (R/R) multiple myeloma, commenting on the role of BCMA loss, and referencing data from recent clinical trials. This interview took place at the 20th International Myeloma Society (IMS) Annual Meeting, held in Athens, Greece."

Interview • Video

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - P2 | N=700 | Enrolling by invitation | Sponsor: Kite, A Gilead Company | Trial completion date: Nov 2026 ➔ Mar 2041 | Trial primary completion date: Nov 2026 ➔ Mar 2041

Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology

Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=17 | Terminated | Sponsor: Kite, A Gilead Company | Active, not recruiting ➔ Terminated; The study was terminated due to lack of efficacy

CAR T-Cell Therapy • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=17 | Active, not recruiting | Sponsor: Kite, A Gilead Company | Trial completion date: Dec 2021 ➔ Jun 2022

CAR T-Cell Therapy • Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - P2; N=700; Enrolling by invitation; Sponsor: Kite, A Gilead Company; Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Hematological Disorders • Hematological Malignancies • Oncology

Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=17; Active, not recruiting; Sponsor: Kite, A Gilead Company; Trial completion date: Nov 2033 ➔ Dec 2021

CAR T-Cell Therapy • Clinical • Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology

A phase 1 multicenter study evaluating KITE-585, an autologous anti-BCMA CAR T-cell therapy, in patients with relapsed/refractory multiple myeloma. (ASCO 2018) - P1; "...After leukapheresis and manufacturing, pts undergo lymphodepleting chemotherapy with fludarabine (30 mg/m2/d) and cyclophosphamide (300 mg/m2/d) for 3 d followed by a single infusion of KITE-585...Key exclusion criteria include plasma cell leukemia, nonsecretory MM, active infection, a history of central nervous system involvement, active autoimmune disease, or prior allogeneic stem cell transplant. The study opened to accrual in October 2017."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Leukemia • Multiple Myeloma

A phase 1, multicenter study evaluating the safety and efficacy of KITE-585, an autologous anti-BCMA CAR T-cell therapy, in patients with relapsed/refractory multiple myeloma. (PubMed, Am J Cancer Res) - "Patients underwent leukapheresis and subsequently received a 3-day conditioning therapy regimen (cyclophosphamide [300 mg/m/day] and fludarabine [30 mg/m/day]). Median peak CAR T-cell expansion was low (0.98 cells/μL), as were median peak serum levels of CAR-associated cytokines, including interferon-γ (61.45 pg/mL) and interleukin-2 (0.9 pg/mL). KITE-585 demonstrated a manageable safety profile; however, the limited CAR T-cell expansion and associated lack of anti-tumor response in patients with RRMM treated with KITE-585 is consistent with the minimal CAR T-cell activity observed."

CAR T-Cell Therapy • Clinical • IO biomarker • Journal • P1 data • CNS Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Oncology • IFNG • IL2

Selectivity and specificity of engineered T cells expressing KITE-585, a chimeric antigen receptor targeting B-cell maturation antigen (BCMA) (AACR 2017) - "One such technique is to use adoptive transfer of engineered autologous T cells expressing a chimeric antigen receptor (CAR) directed against a tumor antigen. These studies highlight the tractability of this cell microarray approach for determining the specificity of novel CAR constructs expressed in T cell. Demonstrating the selectivity and specificity of anti-BMCA CAR T cells further supports the progression of KITE-585 towards Phase 1 clinical studies in MM patients."

CAR T-Cell Therapy • Biosimilar • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology

Development of KITE-585: A fully human BCMA CAR T-cell therapy for the treatment of multiple myeloma (AACR 2017) - "One such approach is to use adoptive transfer of engineered autologous T cells expressing a chimeric antigen receptor (CAR) directed against malignant cells. The results of these studies highlight the potential of targeting BCMA with adoptive transfer of engineered T cells for the treatment of MM. Given these positive findings, progress towards Phase 1 clinical studies in MM patients with KITE-585 is continuing."

CAR T-Cell Therapy • Biosimilar • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology

"$KITE $GILD A Study Evaluating the Safety and Efficacy of KITE-585 in Subjects With Relapsed/Refractory MM https://t.co/z8RA622WiH" (@DrPaulyDeSantis)

Clinical • Biosimilar • Women's Health

KITE-585: Completion of enrollment in P1a trial (NCT03318861) of anti-BCMA CAR T in multiple myeloma in Q4 2018 (Gilead) - Q3 2018 Results

Enrollment status • Hematological Malignancies • Multiple Myeloma • Oncology

Kite licenses antibodies and establishes collaboration with Teneobio in multiple myeloma (Gilead Press Release) - "Kite...and Teneobio, Inc. announced the companies have entered into a license and collaboration agreement through which Kite will receive exclusive rights to certain antibodies directed to B-cell maturation antigen (BCMA)....Kite and Teneobio will also collaborate on the discovery of antibodies directed to four additional targets, using Teneobio’s proprietary Human Heavy-Chain Antibodies (UniAb®) platform, to be used in CAR T cell therapies for multiple myeloma and other cancers."

Licensing / partnership

"#ASCO19 $KITE $GILD KITE-585, BCMA Ph1 study in MM still under embargo https://t.co/GqzMtNL0iM" (@BursatilBiotech)

A Study Evaluating the Safety and Efficacy of KITE-585 in Subjects With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=17; Active, not recruiting; Sponsor: Kite, A Gilead Company; Recruiting ➔ Active, not recruiting; N=64 ➔ 17; Trial completion date: Oct 2032 ➔ Nov 2033; Trial primary completion date: Oct 2019 ➔ May 2019

CAR T-Cell Therapy • Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

Product discontinued (FierceBiotech) - P1, Multiple Myeloma

Discontinuation

"Let me just get this straight: a PRECLINICAL asset (KITE-585) had an $820m carrying value on $GILD 's balance sheet?" (@JacobPlieth)

Preclinical

"Human ScFv, CD28 co-stim, but nothing yet suggests that KITE-585 is best in class $GILD #JPM19 https://t.co/rJPeLShYeg $BLUE $CELG $BMY" (@JacobPlieth)