Outcomes of patients with up to 6 years of follow-up from a phase 2 study of idelalisib for relapsed indolent lymphomas

Abstract

The phase 2 study of idelalisib monotherapy for indolent non-Hodgkin lymphomas (iNHLs) was completed in 2018; final efficacy and safety data with up to 6.7 years long-term follow-up are reported. Patients with iNHL refractory to both rituximab and an alkylating agent were enrolled and received 150 mg idelalisib twice daily (N = 125). Idelalisib resulted in an overall response rate of 57.6% with 34.4% continuing therapy for ≥12 months. The median progression-free survival and duration of response were 11.0 and 11.8 months for follicular lymphoma, 22.2 and 20.4 months for lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia (LPL/WM), and 6.6 and 18.4 months for marginal zone lymphoma (MZL). Median overall survival after extended follow-up was 48.6 (95% CI 33.9, 71.7) months. Long-term follow-up did not reveal new safety concerns. These data indicate beneficial outcomes with longer follow-up after idelalisib for treatment of iNHL including in patients with LPL/WM and MZL.

Keywords:

• Idelalisib
• PI3K inhibitor
• indolent non-Hodgkin lymphoma
• follicular lymphoma
• marginal zone lymphoma
• Waldenström’s macroglobulinemia

Acknowledgements

The authors would like to thank Lin Gu for contributions to biostatistical analysis. Medical writing and editorial support were provided by Katelynn Milora, PhD; and Nicole Seneca, PhD, of AlphaScientia, LLC (San Francisco, CA) and funded by Gilead Sciences, Inc.

Disclosure statement

NDW-J has participated in advisory boards for ADC Therapeutics, Bayer, CALIB-R, Gilead, Karyopharm, Regeneron, and Verastem. SJS reports research grants and honoraria from AbbVie, Acerta, Celgene, Genentech, Gilead, Novartis, Merck, and Pharmacyclics; honoraria from AstraZeneca, Loxo Oncology, Nordic Nanovector, and Pfizer; and has a patent on combination therapies of CAR and PD-1 inhibitors with royalties paid to Novartis. SdV has consulted for Verastem and is a member of the board for Portola Pharmaceuticals. GS reports consulting or participation on advisory boards for AbbVie, Autolus, Celgene, Gilead, Epizyme, Janssen, Karyopharm, Kite, Merck, MorphoSys, Novartis, Roche, Servier, and Takeda; and has participated in educational events for AbbVie, Amgen, Celgene, Gilead, Janssen, Kite, MorphoSys, Novartis, Roche, Servier, and Takeda. WJJ reports grants from AbbVie, AstraZeneca, Bayer, BeiGene, Gilead, Janssen, Mei Pharma, and TG Therapeutics. CRF reports a consulting or advisory role with AbbVie, Bayer, Celgene (unpaid), Denovo Biopharma, Genentech/Roche (unpaid), Gilead, OptumRx, Karyopharm, Pharmacyclics/Janssen, Spectrum; research funding from AbbVie, Acerta, Celgene, Gilead, Genentech/Roche, Janssen Pharmaceutical, Millennium/Takeda, Pharmacyclics TG Therapeutics, Burroghs Wellcome Fund, Easter Cooperative Oncology Group, National Cancer Institute, and V Foundation. AV reports personal fees from Amgen, Gilead, Kite, Novartis, and Roche. IWF reports research funding and consultancy from AbbVie, AstraZeneca, BeiGene, Gilead Sciences, Janssen, Juno Therapeutics, Kite Pharma, MorphoSys, Pharmacyclics, Roche, Seattle Genetics, Takeda, TG Therapeutics, Unum Therapeutics, and Verastem; research funding from Acerta Pharma, Agios, AqQule, Calithera Biosciences, Celgene, Constellation Pharmaceuticals, Curis, Forma Therapeutics, Forty Seven, Genentech, IGM Biosciences, Incyte, Infinity Pharmaceuticals, Karyopharm Therapeutics, Loxo, Merck, Novartis, Pfizer, Portola Pharmaceuticals, Rhizen Pharmaceuticals, Teva, Trillium Therapeutics, and Triphase Research & Development Corp; and consultancy for Curio Science, Great Point Partners, Iksuda Therapeutics, Nurix Therapeutics, and Yingli Pharmaceuticals. PM reports consulting for Acerta/AstraZeneca, ADCT, Bayer, BeiGene, Bristol-Myers Squibb/Cel-gene, Celldex, Cellectar, I-MAB, Janssen, Karyopharm, Gilead/KITE, Incye/MorphSys, Regeneron, Sandoz, TeneoBio, and Verastem. NR and GX are employees of Gilead. AKG reports grants and nonfinancial research support from Bristol-Myers Squibb, Effector, Janssen, Merck, Pfizer, Seattle Genetics, Takeda, and Teva; personal fees and nonfinancial support from Acerta, Amgen, Aptevo, Asana Bio, BRIM bio, Compliment, Seattle Genetics, Gilead, I-Mab-pharma, Incyte, Janssen, Sanofi, Pfizer, and Spectrum.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its Supplementary materials.

Additional information

Funding

This study was funded by Gilead Sciences, Inc. (Foster City, CA).