Welcome to your weekly digest of approaching regulatory and clinical read outs.
The 2013 Eular meeting is taking place in Madrid from June 12 - 15. Data is expected on oral drugs in RA, with Eli Lilly noting promising extension data on its Jak-1/2 inhibitor baricitinib while Galapagos will present on its Jak-1 inhibitor GLPG0634, which underwhelmed in phase II. Meanwhile results are on the horizon from Immunocelluar Therapeutics' lead product, cancer vaccine ICT-107, in the shape of an interim analysis of its phase IIb study in frontline glioblastoma.
The European League Against Rheumatism annual congress June 12 – 15
Eli Lilly and Incyte will be giving a 52-week update on baricitinib's phase IIb RA study. Analysts at JMP Securities note that efficacy of the Jak-1/2 inhibitor remained consistent between weeks 24 and 52, indicating a strong durability of benefit. The rates of infection were also similar.
While the data is encouraging and, according to analysts at BMO Capital, on par with biologics and Pfizer’s Xeljanz (tofacitinib), barcitinib is at least three years behind Xeljanz. The phase III programme is set to complete in the second half of 2014, with data expected on patients who have inadequately responded to biologics. Consensus data from EvaluatePharmashows 2018 sales of $343m.
Meanwhile Pfizer will be presenting data on Xeljanz itself. The Jak-3 inhibitor was approved at the end of last year with a boxed warning for infections and malignancy (US approval makes tofa a potential blockbuster – eventually, November 7, 2012). Details on the relationship between lymphocyte counts and the risk of infection from five randomised phase III trials and two open-label long-term extension studies in RA will be released.
Very low lymphocyte counts have been associated with an increased risk of serious and opportunistic infections, so analysts believe the data could help inform monitoring programmes to help mitigate the risks of the drug. European regulators declined to approve Xeljanz earlier this year. The EMA said that it could not be certain that the drug's benefit outweighed the infection and tumour risk (Xeljanz train derails in Europe, April 26, 2013).
Lastly, Belgium-based Galapagos will present phase II data on GLPG0634. A four-week dose-ranging trial of the Jak-1 inhibitor, under development with Abbvie, showed a relatively high placebo response. ACR20 scores were 41% for placebo and 65% for the 300mg GLPG0634 dose; this difference was not statistically significant. The ACR50 difference was significant, though, at 6% for placebo versus 45% for the drug. GLPG0634 was well tolerated and no serious adverse events were seen.
Abbott paid $150m upfront to corner GLPG0634 early last year and successful clinical results will trigger a full licensing deal, meaning Galapagos needs the drug to deliver (Abbott-Galapagos deal ranks amongst largest for phase II asset,February 29, 2012). However, with lacklustre phase II results Galapagos has some way to go to prove that GLPG0634 is a future competitor in RA, particularly against Xeljanz.
Immunocellular Therapeutics: ICT-107
The data monitoring committee overseeing the phase IIb study of Immunocellular's glioblastoma candidate is set to perform an interim safety and futility review after 32 events occur and the company has guided to that read out in the second quarter of the year. Topline results from the 278-patient trial, including overall survival (OS) and progression-free survival (PFS), are expected by year end.
ICT-107 is a dendritic cell vaccine, and is the company’s lead pipeline candidate. In a small phase I trial in 16 patients, median overall survival exceeded 38 months in the ICT-107 group compared with 14.6 months for historic standard of care - radiotherapy plus temozolomide. Median progression free survival was 16.9 months compared with the historic median of 6.9 months. There were no serious adverse events; side-effects included skin rash, fatigue and pruritus.
Cancer vaccines have a chequered past, and there has also been limited success in developing new effective treatments for glioblastoma (Therapeutic Focus – Avastin provides glimmer in glioblastoma but progress still slow, August 17, 2012). Avastin is approved in the US in patients with relapsed glioblastoma but results at Asco from the AVAglio study in newly diagnosed glioblastoma produced disappointing results, with the agent failing to extend the life of patients.
Cilengitide, an integrin inhibitor also tested in newly diagnosed glioblastoma, also failed to prolong either overall or progression-free survival when added on top of temozolomide and radiotherapy, the drug's developer said at Asco (Asco – Little fanfare for GemVax and Merck KGaA setbacks, June 4, 2013).
EvaluatePharma's consensus forecasts put 2018 sales of ICT-107 at $152m; Immunocellular ended the first quarter with just $24.1m in cash. While the results of the phase I trial were encouraging, the small size of the trial and the lack of an active control arm, on top of the intractable nature of brain cancer, mean a positive outcome is far from certain.
All information is sourced to analyst notes and the EvaluatePharma Calendar of Events tool.