ASCO 2014|May 30, 2014 10:22 pm

ASCO 2014 Saturday Melanoma Preview


Developmental Therapeutics AM session:

Oral abstract:

Phase 1 study of the BRAF inhibitor dabrafenib (D) with or without the MEK inhibitor trametinib (T) in combination with ipilimumab (Ipi) for V600E/K mutation–positive unresectable or metastatic melanoma (MM).

[This is interesting because the initial attempt at combining the BRAF inihibitor Vemurafenib (Zelboraf) with Ipilimumab (Yervoy) was stopped due to frequent dose-limiting liver toxicity. From the abstract, it is possible that dabrafenib (Tafinlar) might combine more readily with Yervoy although there are other significant toxicities apparently.]

 

Melanoma General Poster session:

 These are the posters that on first glance seem most interesting:

Abstract #9045 View Abstract

Final overall survival from a phase 3 trial of nab-paclitaxel versus dacarbazine (DTIC) in chemotherapy-naive patients with metastatic melanoma.

Evan Hersh, MD

Poster Board: #249

[Final results of (now) older trial looking at cytotoxic chemotherapy for metastatic melanoma. The concept almost seems quaint at this point.]

 

Abstract #9047 View Abstract

Biochemotherapy with interleukin-2 for metastatic melanoma: Long-term results in 100 patients.

David R. Minor, MD

Poster Board: #251

[Some persist in looking at biochemotherapy (multiple cytotoxic chemo agents plus interferon and interleukin-2), which was heavily in vogue in mid 1990s, but now seems like something you vaguely remember (Oh yeah, I remember that regimen…)]

 

Abstract #9050 View Abstract

Randomized, double-blind phase II trial of NY-ESO-1 ISCOMATRIX vaccine and ISCOMATRIX adjuvant alone in patients with resected stage IIc, III, or IV malignant melanoma.

Jonathan S. Cebon, MBBS, FRACP, PhD

Poster Board: #254

[NY-ESO-1 vaccines may prove to be important as priming agents for the emerging standards in immunotherapy. It is unlikely at this point that any injectable vaccine will succeed as a monotherapy but may end up useful in combination with a drug like Yervoy or an anti-PD-1 agent.]

 

Abstract #9054 View Abstract

Improved median overall survival (OS) in patients with metastatic melanoma (mM) treated with high-dose (HD) IL-2: Analysis of the PROCLAIM 2007-2012 national registry.

Gregory A. Daniels, MD, PhD

Poster Board: #258

[Like biochemotherapy, some Centers persist in treating increasingly selective subsets of patients with high dose interleukin-2. The future utility of this drug and regimen, I believe, will depend on the ability to effectively select those most likely to benefit from this drug (and this drug ONLY), a group of patients destined to progressively shrink as new immunotherapy agents are approved and used.]

 

Abstract #9061 View Abstract

Vemurafenib treatment in patients with BRAF-mutated melanoma failing MEK inhibition with trametinib.

Helen Gogas

Poster Board: #265

[An interesting question to examine: can patients who fail one type of targeted inhibitor still respond to another type, even if the pathway is the same?]

 

Abstract #9066 View Abstract

A randomized phase II study of ipilimumab (IPI) with carboplatin and paclitaxel (CP) in patients with unresectable stage III or IV metastatic melanoma (MM).

Rahima Jamal, MD

Poster Board: #270

[Combining cytotoxic chemotherapy like carboplatin and paclitaxel with immunotherapy like ipilimumab doesn’t intrinsically make sense to me, since empirically any cytotoxic agent that kills white blood cells (in other words, all of them to some extent) could potentially diminish the effectiveness of an immunotherapy that (in theory) requires a robust immune system with abundant white blood cells to work.]

 

Abstract #9067 View Abstract

Predictive importance of ulceration on the efficacy of adjuvant interferon-a (IFN): An individual patient data (IPD) meta-analysis of 15 randomized trials in more than 7,500 melanoma patients (pts).

Stefan Suciu, MSc, PhD

Poster Board: #271

[Large study looking at the biologic significance of ulceration and its relationship to response to interferon therapy.]

 

Abstract #9075^ View Abstract

Phase II study of vemurafenib in patients with locally advanced, unresectable stage IIIc or metastatic melanoma and activating exon 15 BRAF mutations other than V600E.

Sigrun Hallmeyer, MD

Poster Board: #279

[Almost all BRAF mutations are at the V600 location, but about 1/20 are mutations other than V600E. Do these melanomas still respond to BRAF inhibitors that were developed to target V600E mutations?]

 

Abstract #9076 View Abstract

Outcome with stereotactic radiosurgery (SRS) and ipilimumab (Ipi) for malignant melanoma brain metastases (mets).

Sana Shoukat, MD

Poster Board: #280

[A very relevant clinical question regarding the efficacy of Ipilimumab in the treatment of melanoma brain metastases, particularly when combined with stereotactic radiosurgery.]

 

Abstract #9078 View Abstract

Safety and clinical activity of combining systemic ipilimumab with isolated limb infusion in patients with in-transit melanoma.

Charlotte Eielson Ariyan, MD, PhD

Poster Board: #282

[A case of a hammer looking for a shrinking nail; with the approval of effective systemic therapies for unresectable stage 3 melanoma, the indications for isolated limb infusion (which has never improved survival and has significant toxicity) are receding.; UNLESS the regional chemotherapy increases the immunogenicity (how good a target for the immune system) of the tumor.]

 

Abstract #9081 View Abstract

Vismodegib for advanced basal cell carcinoma: Duration of response after vismodegib discontinuation and response to vismodegib retreatment upon disease progression.

Aleksandar Sekulic, MD, PhD

Poster Board: #285

[Important clinical question for a drug approved after a very small study without long term followup.]

 

Abstract #9098 View Abstract

A phase IB study of ipilimumab with peginterferon alfa-2b for patients with unresectable stages IIIB/C/IV melanoma.

Ragini Reiney Kudchadkar, MD

Poster Board: #302

[An interesting combination of two different immunotherapies, which can unfortunately lead to significant additive toxicities or perhaps enhanced responses?]

 

Abstract #9101 View Abstract

A phase I trial of BKM120 combined with vemurafenib in BRAFV600E/k mutant advanced melanoma.

Alain Patrick Algazi, MD

Poster Board: #305

[Another interesting early combination therapy. At older ASCO’s this may have warranted a larger audience.]

 

These are posters describing trials in progress, largely without any results at this point:

 

Abstract #TPS9102 View Abstract

NEMO: A phase 3 trial of binimetinib (MEK162) versus dacarbazine in patients with untreated or progressed after first-line immunotherapy unresectable or metastatic NRAS-mutant cutaneous melanoma.

Keith Flaherty, MD

Poster Board: #306A

 

Abstract #TPS9104 View Abstract

A phase II study to assess vismodegib in the neoadjuvant treatment of locally advanced basal cell carcinoma (laBCC): The Vismodegib Neoadjuvant (VISMONEO) study.

Laurent Mortier, MD, PhD

Poster Board: #307A

 

Abstract #TPS9105 View Abstract

Phase I-II study of the combination vemurafenib plus peg-interferon in advanced melanoma patients harboring the V600BRAF mutation.

Paolo Antonio Ascierto, MD

Poster Board: #307B

 

Abstract #TPS9106 View Abstract

Phase II, open-label study of dabrafenib plus trametinib in patients with BRAF mutation-positive melanoma brain metastases: A GSK-sponsored trial.

Michael A. Davies, MD, PhD

Poster Board: #308A

 

Abstract #TPS9108 View Abstract

Phase 1 study of MEDI4736, an anti-PD-L1 antibody, in combination with dabrafenib and trametinib or trametinib alone in patients with unresectable or metastatic melanoma.

Michael S. Gordon, MD

Poster Board: #309A

 

bstract #TPS9115 View Abstract

NLG-0304: A phase 2B study of ipilimumab with or without dorgenmeltucel-L (HyperAcute-Melanoma) immunotherapy for patients with stage IV melanoma.

Adam I Riker, MD

Poster Board: #312B

 

Abstract #TPS9117 View Abstract

Phase 1/2 trial of the indoleamine 2,3-dioxygenase pathway (IDO) inhibitor indoximod plus ipilimumab for the treatment of unresectable stage 3 or 4 melanoma.

Eugene Kennedy, MD

Poster Board: #313B

 

 

Eric Whitman, MD

Senior Editor

TheMelanomaCenter.com

 

 

 

 

 


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