Columvi improves OS in R/R DLBCL in phase III trial

Inavolisib combination demonstrates 57% PFS in breast cancer indication

The phase III INAVO120 study evaluating inavolisib in combination with palbociclib (Ibrance) and fulvestrant as a first-line treatment for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer, demonstrated positive results.

January 05, 2024

Vol.50 No.01

Clinical Roundup

Kadcyla demonstrates OS benefit in breast cancer indication

The phase III KATHERINE study in people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) treatment demonstrated positive long-term follow-up data.

January 05, 2024

Vol.50 No.01

Clinical Roundup

Phase III ALINA study: Alecensa reduces risk of disease recurrence/death in NSCLC

In the phase III ALINA study, Alecensa (alectinib) reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in people with completely resected stage 1B (tumor ≥4 cm) to 3A (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.

October 27, 2023

Vol.49 No.40

Drugs & Targets

FDA grants priority review to odronextamab for R/R follicular lymphoma and R/R diffuse large B-cell lymphoma

FDA has accepted for priority review the Biologics License Application for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies.

October 06, 2023

Vol.49 No.37

Clinical Roundup

Phase III data demonstrate Alecensa reduces disease recurrence in the early setting for ALK-positive NSCLC

The phase III ALINA study evaluating Alecensa (alectinib) compared with platinum-based chemotherapy met its primary endpoint of disease-free survival at a prespecified interim analysis.

September 08, 2023

Vol.49 No.33

Drugs & Targets

EMA validates odronextamab application for R/R follicular lymphoma and DLBCL

The European Medicines Agency has accepted for review the Marketing Authorization Application for odronextamab to treat adult patients with relapsed/refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, who have progressed after at least two prior systemic therapies. The EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL.

September 08, 2023

Vol.49 No.33

Columvi improves OS in R/R DLBCL in phase III trial

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Inavolisib combination demonstrates 57% PFS in breast cancer indication

Kadcyla demonstrates OS benefit in breast cancer indication

Phase III ALINA study: Alecensa reduces risk of disease recurrence/death in NSCLC

FDA grants priority review to odronextamab for R/R follicular lymphoma and R/R diffuse large B-cell lymphoma

Phase III data demonstrate Alecensa reduces disease recurrence in the early setting for ALK-positive NSCLC

EMA validates odronextamab application for R/R follicular lymphoma and DLBCL

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