Company

Product

Description

Indication

Status

Aravive Inc., of Houston

AVB-500

Recombinant fusion protein that binds to GAS6

Ovarian cancer

Data from initial 12 patients in ongoing phase Ib portion of phase Ib/II study in platinum-resistant recurrent disease showed treatment led to early proof of concept in both cohorts – 1 testing AVB-500 with pegylated liposomal doxorubicin (PDL) and 1 testing combination with paclitaxel (PAC); clinical benefit (partial response and stable disease) seen in 7 patients (58%); PRs in 5 patients (42%); mean response rate was 50% for AVB-500+PAC and 33% for AVB-500+PLD

Bergenbio ASA, of Bergen, Norway

Bemcentinib

Axl tyrosine kinase receptor inhibitor

Metastatic non-small-cell lung cancer

Phase II trial with pembrolizumab found combo well-tolerated with "promising" efficacy in previously treated NSCLC patients, particularly in those with AXL expression in tumor, immune and stromal cells

Bergenbio ASA, of Bergen, Norway

Bemcentinib

Axl tyrosine kinase receptor inhibitor

Stage IV melanoma

Phase Ib/II study of bemcentinib in combination with either dabrafenib/trametinib or pembrolizumab found bemcentinib is well-tolerated

EMD Serono Inc., of Rockland, Mass., a unit of Merck KGaA

Bavencio (avelumab)

PD-L1 inhibitor

Metastatic renal cell carcinoma

Analyses from the phase III Javelin Renal 101 study support efficacy of Bavencio plus axitinib across multiple subgroups of patients with advanced renal cell carcinoma

Incyte Corp., of Wilmington, Del.

Pemigatinib

FGF1/2/3 receptor antagonist

Cholangiocarcinoma

Updated phase II data showed 36% objective response rate and median progression-free survival of 6.9 months; planning NDA filing before year-end

Janssen Research & Development LLC, of Horsham, Pa., a unit of Johnson & Johnson

Erleada (apalutamide)

Androgen receptor antagonist

Hormone-refractory prostate cancer

Updated, longer-term results from pivotal phase III Spartan study with median follow-up of 41 months found 4-year overall survival rates were 72.1% for patients treated with Erleada vs. 64.7% for patients treated with placebo

Northern Biologics Inc., of Toronto

MSC-1

Leukemia inhibitory factor receptor antagonist; aminopeptidase N inhibitor

Advanced solid tumor

Phase Ia study found candidate well-tolerated with no dose-limiting toxicities at any dose; prolonged stable disease (>16 weeks) was observed in 9 of 41 enrolled patients

Roche Holding AG, of Basel, Switzerland

Tecentriq (atezolizumab)

PD-1 inhibitor

Metastatic non-small-cell lung cancer

Phase III IMpower110 study showed Tecentriq monotherapy helped people with advanced NSCLC with high PD-L1 expression live longer vs. chemotherapy alone; improved overall survival by 7.1 months compared with chemotherapy alone

Roche Holding AG, of Basel, Switzerland

Tecentriq (atezolizumab)

PD-1 inhibitor

Hepatocellular carcinoma

Phase I combination study with Avastin (bevacizumab) confirmed objective response rate of 36%, reduction in risk of disease worsening or death by 45% compared with Tecentriq monotherapy

Samsung Bioepis Co. Ltd., of Incheon, South Korea

SB-8 (bevacizumab biosimilar)

VEGF ligand inhibitor

Non-small-cell lung cancer

In a phase III study, SB-8 demonstrated equivalent efficacy in terms of risk ratio of objective response rate to reference Avastin (bevacizumab) in patients with metastatic or recurrent NSCLC; MAA accepted by the EMA

Notes

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