Oncology Daily Report: 01/24/2024

Phase 3 Studies

Diffuse large B-cell lymphoma

A phase 3 open-label study (HLX01-NHL03) investigated the effect of HLX01 (HanliKang(®)), a rituximab biosimilar, in 316 patients with previously untreated diffuse large B-cell lymphoma and found that the 5-year overall survival rates were 81.0% (95% CI: 74.9-87.5%) and 75.4% (95% CI: 68.9-82.6%) in the H-CHOP and R-CHOP groups, respectively, with no significant difference in 5-year OS or PFS (1).

Reference

Qin Y, Song Y, Wang D, Bai O, Feng J, Sun X, Qiu L, Yang J, Yang Y, Wang Z, Hu J, Wang H, Su H, Jin Z, Qian W, Jin C, Zhang M, Yu D, Liu L, Chen G, Li Y, Sun T, Jin J, Bao H, Du X, Zhou H, Fu G, Shi Y. Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study. BMC Cancer. 2024 Jan 24;24(1):124. doi: 10.1186/s12885-024-11876-9. PMID: 38267866; PMCID: PMC10809427.

Prostate Cancer

A multicenter, non-inferiority, randomized phase 3 trial investigated the effect of two moderate hypofractionated radiotherapy (HFRT) regimens in patients with prostate cancer and found that both regimens are safe and equivalent in terms of acute grade ≥2 gastrointestinal toxicity (1). The study compared 56 Gy in 4 weeks (Arm A) with 67 Gy in 5 weeks (Arm B) and reported no significant difference in acute gastrointestinal or urinary toxicity between the two arms, confirming the safety and equivalence of both HFRT regimens in terms of acute gastrointestinal toxicity.

Reference

Fonteyne V, Berghen C, Van Praet C, Vanderstraeten B, Verbeke S, Villeirs G, Colman R, Vanneste B, Ost P, De Meerleer G, Lumen N. Moderate hypofractionated radiotherapy for prostate cancer: 3-year toxicity results of a multicentre randomized phase 3, non-inferiority trial. Radiother Oncol. 2024 Jan 24;193:110089. doi: 10.1016/j.radonc.2024.110089. Epub ahead of print. PMID: 38278333.

Phase 2 Studies

Diffuse large B-cell lymphoma

A phase 2 randomized open-label study investigated the effect of oral darolutamide monotherapy versus androgen deprivation therapy in 61 men with hormone-sensitive prostate cancer and found that 23 (100%) evaluable darolutamide patients achieved a PSA decline of >80% at week 24, with a median (range) decrease of -99.1% (-91.9%, -100%) (1).

Reference

Tombal BF, Gomez-Veiga F, Gomez-Ferrer A, López-Campos F, Ost P, Roumeguere TA, Herrera-Imbroda B, D'Hondt LA, Quivrin M, Gontero P, Villà S, Khaled H, Fournier B, Musoro J, Krzystyniak J, Pretzenbacher Y, Loriot Y. A Phase 2 Randomized Open-label Study of Oral Darolutamide Monotherapy Versus Androgen Deprivation Therapy in Men with Hormone-sensitive Prostate Cancer (EORTC-GUCG 1532). Eur Urol Oncol. 2024 Jan 24:S2588-9311(24)00034-8. doi: 10.1016/j.euo.2024.01.009. Epub ahead of print. PMID: 38272747.

Phase 1 Studies

Colorectal and pancreatic carcinoma

A phase 1 open-label study (MEDIPLEX, NCT02777710) investigated the effect of pexidartinib, a CSF-1R-directed tyrosine kinase inhibitor (TKI), and durvalumab (anti-PD-L1) in 47 patients with advanced colorectal and pancreatic carcinoma and found no unexpected toxicities, one (2%) high microsatellite instability CRC patient had a partial response, and seven (15%) patients experienced stable disease as their best response (1).

Reference

Voissière A, Gomez-Roca C, Chabaud S, Rodriguez C, Nkodia A, Berthet J, Montane L, Bidaux AS, Treilleux I, Eberst L, Terret C, Korakis I, Garin G, Pérol D, Delord JP, Caux C, Dubois B, Ménétrier-Caux C, Bendriss-Vermare N, Cassier PA. The CSF-1R inhibitor pexidartinib affects FLT3-dependent DC differentiation and may antagonize durvalumab effect in patients with advanced cancers. Sci Transl Med. 2024 Jan 24;16(731):eadd1834. doi: 10.1126/scitranslmed.add1834. Epub 2024 Jan 24. PMID: 38266104.