Specific patterns of response
- As it can take some time to prime the immune system to fight the tumour, it is not surprising that many advanced (unresectable or metastatic) melanoma patients display atypical, delayed responses to YERVOY™. (2)
- Some patients respond in a conventional manner to YERVOY™; in others, tumour burden may decline very slowly. (3)
- In some patients, response to YERVOY™ may occur after an initial increase in tumour burden, yet in others, the response may occur after the appearance of new tumours. (3)
Slow, steady decline in tumour burden
Late response after initial progression
New lesion appears and then declines along with target lesion
Specific assessment needs:
- Tumour response to YERVOY™ should be assessed only after completion of induction therapy, 12 weeks after treatment initiation to allow YERVOY™ time to trigger an anti-tumour immune response (1,2,4)
- Tumour response assessment prior to this time may fail to detect the delayed tumour responses characteristic of YERVOY™, resulting in some responses being mistaken for progressive disease and potentially premature discontinuation of treatment. (2,3)
- In the pivotal trial, further assessments were performed at week 16 and 24 and every 3 months thereafter. (4)
Liver function tests and thyroid function tests should be evaluated at baseline and before each dose of YERVOY™. In addition, any signs or symptoms or immune-related adverse reactions, including diarrhea and colitis, must be assessed during treatment with YERVOY™ . (1)
1. YERVOY™ Summary of Product Characteristics.
2. Hoos A et al. J Natl Cancer Inst. 2010 Sep 22;102(18):1388-1397.
3. Wolchok JD et al. Clin Cancer Res. 2009;15(23):7412-7420.
4. Hodi FS et al. Improved Survival with Ipilimumab in Patients with Metastatic Melanoma. N Engl J Med. 2010;363(8):711-723.