ESMO roundup – 11 September


Preliminary data for Celgene's Abraxane + durvalumab combo showed a benefit in progression-free survival (PFS) and disease control rate (DCR) (the percentage of patients who achieved complete response, partial response and stable disease), indicating that the combination of Abraxane and durvalumab is feasible with manageable toxicity. Abraxane monotherapy also presented promising preliminary efficacy and may be a potential second-line therapeutic option in patients with previously treated advanced stage NSCLC.

Results from AstraZeneca and MedImmune’s phase III PACIFIC trial showed an improvement in PFS of more than 11 months in patients treated with Imfinzi (durvalumab) compared to placebo in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy (CRT).

New data on Ipsen and Exelixis' cabozantinib showed that the renal cell carcinoma drug had clinically meaningful and statistically significant efficacy results on the primary endpoint of PFS, compared to sunitinib, a current standard of care. Specifically, per the IRC review, cabozantinib demonstrated a 52 percent reduction in the rate of disease progression or death (HR = 0.48, 95% CI 0.31-0.74, two-sided P=0.0008). The median PFS for cabozantinib was 8.6 months versus 5.3 months for sunitinib.

Bristol-Myers Squibb announced superior overall survival (OS) results from a phase III study (CheckMate -214) evaluating nivolumab plus ipilimumab versus sunitinib in patients with previously-untreated advanced or metastatic clear cell renal cell carcinoma; in an interim analysis of overall survival (OS), the median OS in a sub-group of patients had not yet been reached for the combination and was 26 months for sunitinib, a current standard of care. The combination also demonstrated an objective response rate – the number of patients who saw a complete or partial reduction in their tumours – of 42%, with 9.4% of patients achieving a complete response, where no detectable sign of cancer remained.

Eisai has announced interim results from the advanced renal cell carcinoma cohort of Study 111 of Kisplyx (lenvatinib) in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab). The results demonstrate that the combination achieved a confirmed objective response rate (ORR) at week 24 of 63% (95% CI: 44 – 80), and disease control rate, a secondary endpoint, was 96%.

Novartis announced results from a Phase III study of 870 patients with stage III BRAF V600E/K mutation-positive melanoma treated with the combination of Tafinlar (dabrafenib) and Mekinist (trametinib). Findings from the COMBI-AD study, which met its primary endpoint, found a statistically significant 53% reduction in the risk of death or recurrence in patients treated with the BRAF and MEK inhibitor combination therapy versus placebo.

Clovis Oncology announced the first presentation of a comprehensive dataset from its Phase 3 ARIEL3 study of Rubraca (rucaparib). The ARIEL3 study successfully achieved its primary endpoint and key secondary endpoint, demonstrating improved PFS in each of the three populations studied.

Results from the phase 3 LATITUDE clinical trial showed that treatment with Janssen’s Zytiga (abiraterone acetate) plus prednisone, in combination with androgen deprivation therapy (ADT), demonstrated clinically meaningful and statistically significant improvements in a range of patient reported outcomes in patients with newly diagnosed, high-risk, metastatic hormone-sensitive prostate cancer (mHSPC), compared to ADT alone. The study findings indicated that the treatment significantly delayed time to progression of worst pain intensity, pain interference, worst fatigue and compared to ADT plus placebos. Findings also show a significant improvement in health-related quality of life (HRQoL), which includes several measures such as physical and emotional wellbeing, demonstrating a reduction in risk of HRQoL degradation.