Welcome to your weekly digest of approaching regulatory and clinical readouts.
All information is sourced to analyst notes and the EvaluatePharma Calendar of Events tool.
Results are expected shortly from a phase III trial of Afinitor in advanced hepatocellular cancer. The 531-patient trial called Evolve-1 is testing the drug along with best supportive care (BSC) against placebo and BSC. Patients have previously failed on Nexavar, the current market leader.
Analysts at Edison note that in a single-arm, phase I/II study the drug produced a moderate response rate (4%) with a median progression-free survival and overall survival of 3.8 and 8.4 months respectively. However, despite the modest efficacy the phase III trial could yield a positive outcome because the control is BSC.
Afinitor is an mTOR inhibitor and has been approved in a number of indications, the most recent and lucrative of which is advanced breast cancer, and 2018 sales forecast could reach $1.3bn, according to EvaluatePharma. Hepatocellular cancer is a much smaller indication, and is expected to add $123m to 2018 sales.
Given the number of second-line threats on the horizon, including Lillys ramucirumab, Afinitor is just one competitor in a race to challenge Nexavar’s dominance (Therapeutic Focus – Liver cancer focus switches to second-line as Nexavar proves a tough nut to crack, October 24, 2012).
Amgen: AMG 386
Progression-free survival data are expected in the coming months from a pivotal phase III trial of Amgen’s AMG 386 (trebananib) in combination with paclitaxel in recurrent ovarian cancer. The company has also noted that the more important overall survival from the trial, Trinova-1, will be announced next year.
Meanwhile, a first-line ovarian cancer phase III trial called Trinova-3, which uses the drug in combination with paclitaxel and carboplatin, will read out in 2015.
The project is an anti-angiopoietin peptibody; angiopoietins are growth factors that promote blood vessel growth. By inhibiting the interaction between the ligands angiopoietin-1 and -2 with their receptor, Tie-2, AMG 386 is said to stunt tumour growth (EP Vantage Interview - Amgen infected with enthusiasm for new cancer vaccine, January 31, 2011).
Analysts at Credit Suisse note that Amgen could file in the EU on PFS data, but will likely need to wait for OS data before making a US submission. 2018 sales forecasts for Takeda, which has co-promotion rights in Japan, and Amgen are modest – a combined $19m, according to EvaluatePharma.
Credit Suisse analysts assume that AMG 386 will likely follow a similar path to that of Roche’s Avastin, which suffered US approval setbacks due to uninspiring quality-of-life data (Avastin in ovarian gets EU backing but US will be harder won, September 26, 2011). Ultimately AMG 386 will need a strong clinical benefit to win over the FDA.
European Association for the Study of the Liver meeting
This year’s EASL meeting will take place in Amsterdam, the Netherlands, on April 24-28; abstracts will be released on Monday, April 8.
Analysts at UBS note that three-day viral load data are expected on both Merck & Co's and Gilead’s NS5a inhibitors, which are being tested across most genotypes. Both should have similar resistance coverage to Achillion’s ACH-3102, which the analysts believe could reduce the perceived value of Achillion’s NS5a.
Data are also expected on Bristol-Myers Squibb's NS5a, protease inhibitor and non-nucleoside combination, along with Vertex's VX-222.
Watch out for EP Vantage’s detailed preview of the meeting in the coming weeks.
|Project||Company||Study name||Trial ID|
|Afinitor||Novartis||Phase I/II trial||NCT00516165|