Friday, June 8, 2018

ASCO 2018 - Nivo vs ipi as adjuvant in resected melanoma

Not really news here.  Guess what drug does better and in whom???  Nivo or ipi????  (But, spoiler alert!!!!  As I've been saying, even patients with minimal PD-L1 expression can still gain a response!!!) 

Adjuvant therapy with nivolumab (NIVO) versus ipilimumab (IPI) after complete resection of stage III/IV melanoma: Updated results from a phase III trial (CheckMate 238). Weber, Mandalà, Del Vecchio, ... Ascierto. ASCO 2018.

In the initial report of data from CheckMate 238, at a minimum follow-up of 18 mo, NIVO demonstrated significantly longer recurrence-free survival (RFS) vs IPI in patients (pts) with resected stage III or IV melanoma. Here, we report updated efficacy results from this phase III study with an additional 6 mo of follow-up.
Methods: Eligible pts included those greater than/= to15 yrs of age who underwent complete resection of stage IIIB/C or IV melanoma. 906 pts were randomized 1:1 (stratified by disease stage and PD-L1 status at a 5% cutoff) to receive NIVO 3 mg/kg Q2W (N=453) or IPI 10 mg/kg Q3W for 4 doses, then Q12W (from week 24) (N=453) for up to 1 yr, or until disease recurrence or unacceptable toxicity. The primary endpoint was RFS; distant metastasis-free survival (DMFS) in pts with stage III disease was an exploratory endpoint.
Results:   At a minimum follow-up of 24 mo, RFS continued to be significantly longer for NIVO vs IPI, with 171/453 and 221/453 events, respectively. The 24-mo RFS rates were higher for NIVO vs IPI in subgroups defined by disease stage, PD-L1 expression, and BRAF mutation status (Table). DMFS also continued to be significantly longer for NIVO vs IPI, with 24-mo rates of 70.5% and 63.7%, respectively. Subsequent therapies were received by 31.1% of pts in the NIVO group and 41.1% in the IPI group. Per protocol, there was no additional safety assessment for the current analysis given that all pts had been off study treatment for 100 days at the time of the previous data cutoff.
Conclusions: With extended follow-up, NIVO demonstrated a sustained efficacy benefit vs IPI in pts with resected stage III/IV melanoma at high risk of recurrence, regardless of disease stage, PD-L1 expression, or BRAF mutation status. Clinical trial information: NCT02388906

Sorry about the sad pic.  Best I could do.  ASCO doesn't make this easy.
In this study Stage III and IV melanoma patients had their disease completely removed.  906 of these peeps were randomly assigned to the ipi group (n- 453) or the nivo group (n- 453) (dosage and administration noted above).  Consistently, across all groups, Nivo did better to lengthen recurrence free survival. Not surprisingly the people with a lower stage did better on both drugs.  Meaning folks who were only Stage IIIb progressed less than those who were Stage IV.  BRAF status made basically NO DIFFERENCE with both drugs.  AND....while those with a higher level of PD-L1 expression did a bit better...folks with minimal PD-L1 expression STILL RESPONDED!!!!!!
Okay.  There you go.  Happy Friday!!! - c

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