Astellas Pharma Inc., of Tokyo, and Seattle Genetics Inc., of Bothell, Wash.

Enfortumab vedotin

Antibody-drug conjugate targeting nectin-4

Locally advanced or metastatic urothelial cancer

Tumors shrank in most patients who previously received platinum chemotherapy and a PD-1/L1 checkpoint inhibitor, resulting in an objective response rate of 44%; complete responses were seen in 12% of patients; the median duration of tumor response in the 125-patient phase II trial was 7.6 months

6/3/19

Beigene Ltd., of Cambridge, Mass., and Beijing

Tislelizumab

Anti-PD-1 inhibitor

Nasopharyn-geal carcinoma

Data on 21 patients treated in the indication expansion portion of an open-label phase I/II trial showed 9 patients achieved confirmed partial response and 9 stable disease; clinical benefit was observed regardless of PD-L1 expression; median duration of response was 8.3 months; median progression-free survival was 10.4 months

6/3/19

Chugai Pharmaceutical Co. Ltd., Tokyo

Alecensa (alectinib)

Anaplastic lymphoma kinase inhibitor

First-line treatment for ALK fusion-positive non-small-cell lung cancer

In the phase III study, risk of progression or death was reduced by 63% in the Alecensa arm compared to the Xalkori arm; median progression-free survival was 34.1 months vs. 10.2 months in the Xalkori arm; superiority of Alecensa vs. Xalkori in overall survival was not conclusive and that investigation is continuing

6/3/19

Daiichi Sankyo Co. Ltd., of Tokyo

U3-1402

HER3-targeting antibody-drug conjugate

Metastatic EGFR-mutated TKI-resistant non-small-cell lung cancer

Results from dose-escalation portion of phase I study showed reduction in tumor size in all 16 evaluable patients across all doses, with median best percentage change of -29%

5/31/19

Daiichi Sankyo Co. Ltd., of Tokyo

Pexidartinib

CSF1R inhibitor

Tenosynovial giant cell tumor

In the phase III Enliven study and the phase I extension study, best overall response was 54% by RECIST and 64% by Tumor Volume Score; median duration of response was not reached

6/3/19

Daiichi Sankyo Co. Ltd., of Tokyo

DS-1062

TROP2-targeting antibody-drug conjugate

Advanced non-small-cell lung cancer

Preliminary phase I results in 39 patients showed 3 confirmed and 4 not-yet-confirmed partial responses (PRs) at data cutoff; an additional 3 PRs reported at 8-mg/kg dose since data cutoff

6/3/19

Innovent Biologics Inc., of Suzhou, China, and Eli Lilly and Co., of Indianapolis

Sintilimab

Anti-PD-1 antibody

First-line advanced or metastatic non-small-cell lung cancer

Preliminary phase Ib data in combination with chemotherapy showed objective response rate in nonsquamous and squamous disease of 68.4% and 64.7%, respectively, based on data from 19 and 17 patients, respectively, with at least 1 radiologic efficacy assessment; median progression-free survival was 11.4 months and 6.5 months, respectively

5/31/19

Innovent Biologics Inc., of Suzhou, China, and Eli Lilly and Co., of Indianapolis

Tyvyt (sintilimab)

Monoclonal antibody targeting PD-1

Resectable squamous non-small-cell lung cancer

In a phase Ib study, 8 of 9 patients with a greater than 30% decrease in standardized uptake values (SUV) had a major pathologic response (MPR); in 11 patients with 30% or less decrease in SUV, no patients had a MPR; 10 patients (45.5%) achieved a MPR, including 4 who had a complete pathologic response

6/3/19

Kyowa Hakko Kirin Co. Ltd., of Tokyo

Poteligeo (mogamuli-zumab-kpkc)

Monoclonal antibody targeting CCR4

Relapsed or refractory mycosis fungoides or Sezary syndrome

Post-hoc analysis of the 372-patient phase III Mavoric study showed median time to next treatment was 11 months for Poteligeo compared to 3.5 months for vorinostat; median time to next treatment was longer for Poteligeo compared to vorinostat for subgroups based on disease stage or disease type

6/3/19

Seattle Genetics Inc., of Bothell, Wash., and Tokyo-based Astellas Pharm Inc.

Enfortumab vedotin

Antibody-drug conjugate targeting Nectin-4

Advanced urothelial cancer

In the phase II EV-201 study, objective response rate was 44% in 125 patients; 12% of patients had complete responses; median duration of tumor response was 7.6 months

6/3/19

Notes

The date indicated refers to the BioWorld table in which the news item can be found.

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