Xilonix phase III trial, for those of us who have run out of options

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skypup
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Xilonix phase III trial, for those of us who have run out of options

Postby skypup » Tue Nov 17, 2015 2:11 am

I am posting info about this drug because I believe in the importance of CT as a repository of our collective knowledge.

I have started this trial. Here is a summary of the info I have been able to uncover about it. The drug was originally intended for cachexia patients only, but it was discovered in early phase trials that it was much more robust. It doesn't aim to cure, rather to improve QOL and, in later trials, to extend life. It acts on interleukin-1alpha, is a fully human monoclonal antibody, and works by alleviating the state of chronic inflammation that cancer creates and requires to do some of its dirty work. It is a very mild drug; in early phase trials there were zero grade 3 or 4 toxicities.

PHASE I/II TRIAL (at MD Anderson)
"It was reported that overall, patients constitutional symptoms improved, including reduction in pain and fatigue. A highlight of the report was the finding that almost two-thirds of patients assessed with a new form of X-ray imaging demonstrated physical recovery of lean body mass (which is another way of referring to muscle mass) but moreover, that these same patients had dramatic improvement in overall survival."

"XBiotech is announcing that results from its Phase I/II oncology study conducted at MD Anderson Cancer Center in Houston, TX were published today in Lancet Oncology. The featured article describes the outcome in 52 advanced cancer patients treated with Xilonix™, XBiotech’s novel, non-cytotoxic, anti-tumor therapy. The so called true human antibody therapy was reported to have an excellent safety profile. The report describes comprehensive measures of patient performance during therapy with Xilonix. It was reported that overall, patients constitutional symptoms improved, including reduction in pain and fatigue. A highlight of the report was the finding that almost two-thirds of patients assessed with a new form of X-ray imaging demonstrated physical recovery of lean body mass (which is another way of referring to muscle mass) but moreover, that these same patients had dramatic improvement in overall survival."

PHASE 1 NSCLC (LUNG CANCER) TRIAL
"Self-reported outcomes revealed reductions in pain, fatigue and improvement in appetite. Median survival was 7.6 (IQR 4.4-11.5) months, stratification based on prior anti-EGFR therapy revealed a median survival of 9.4 months (IQR 7.6-12.5) for those pretreated (N = 10) versus a survival of 4.8 months (IQR 4.3-5.7) for those without (N = 6, logrank p = 0.187)."
Note that previous anti-EGFR therapy (Erbitux, Vectibix) improved outcomes even more that just Xilonix alone -- important since many of us have had anti-EGFR therapy.

PHASE III FAST-TRACK STATUS
"XBiotech, a privately held biotechnology company, announced today that the company has been granted Fast Track designation for its anti-cachexia drug Xilonix. The Company's groundbreaking therapeutic antibody was shown in a previous clinical study at MD Anderson Cancer Center in Texas to stop or reverse cachexia in about a third of all advanced cancer patients treated. Anti-tumor and anti-cachexia effects were seen in many different types of cancer. In patients with advanced colorectal cancer, the reversal of cachexia resulted in a dramatic improvement in life expectancy, with patients that responded to treatment having a median survival of 474 days, versus a median of 72 days in others."

PHASE III TRIAL, INTERIM RESULTS
The phase III trial, designed for mCRC patients with cachexia, was halted for interim analysis with the following result:
"The Company disclosed it has used the interim overall survival data in a model to predict the statistical significance of the survival benefit over the projected complete course of the study. This model is said to indicate that, based on the current effect seen with Xilonix, a highly significant result would be obtained upon study completion, well beyond what is necessary for registration."

PHASE 3 TRIAL REOPENED WITH NO CACHEXIA CONSTRAINT
In short, it was so effective that the FDA approved reformulating criteria and continuing the trial without the cachexia constraint. This is big news for us CRC folk.
"The new protocol is said to permit recruitment of all advanced refractory colorectal cancer patients and will be randomized 2:1 against placebo. XBiotech is expecting patients to be enrolled under the revised protocol as early as October this year."
I joined the trial almost immediately after it reopened and have had one infusion of either the drug or the placebo.
The trial is being run by US Oncology, so has many, many centers where it is available throughout the States (and some in Europe, I believe.)

THE CLINICALTRIALS.GOV ENTRY
https://clinicaltrials.gov/ct2/show/stu ... ocs=Y#locn


In my opinion, this is a kind of turning point for cancer research. The drug was formulated to serve a much ignored population: those of us who have run out of chemo options and are facing QOL issues towards end of life. But also very exciting is that such a tolerable drug is showing that it also extends life -- from what I can tell from the reports, more than the new chemo drugs have done (though that won't be known for sure until the trial process is completed.)

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O Stoma Mia
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Re: Xilonix phase III trial, for those of us who have run out of options

Postby O Stoma Mia » Tue Nov 17, 2015 4:34 am

Skypup -

Thank you for posting this important information. I think many members will be interested in this, especially in view of the fact that there appear to be very few Grade 3 or Grade 4 side effects reported.

I look forward to any updates you might have in the future.

Steph20021
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Re: Xilonix phase III trial, for those of us who have run out of options

Postby Steph20021 » Tue Nov 17, 2015 8:56 am

Very cool, thanks for sharing skypup. Hope you are feeling well.
DX 1/31/14 @ 33- SPS-T4a(invades visceral peri), N2a(6/106 LN), M1a(ovary) (Stage 4a) MSS; BRAF V600E
2/1/14-subtotal col, lost R ovary, temp ileo
3/14-9/14- folfox; sepsis
11/14-CT/PET: L ovary met, pelvic met, (?)ghost liver met(?)
12/14-folfiri -13 rds kept me stable from 3/15-6/15
8/15-HIPEC, NED
09/15- cea 0.9
05/16- recurrence in abdo wall and lymph nodes
01/17- pulmonary embolism
02/17- 1 wk radiation to abdo wall
08/16- on folfiri
01/18-folfox
11/18- Beacon trial-encorafenib & cetuximab

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Jack&KatiesMommy
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Re: Xilonix phase III trial, for those of us who have run out of options

Postby Jack&KatiesMommy » Tue Nov 17, 2015 9:19 am

SkyPuo
THANK YOU so much for sharing. This sounds so promising for so many of us. I hadn't heard anything about this before. Please keep us posted. I think of you often. Thank you for all that you do for everyone here.
Cynthia
Cynthia
Mommy to Jack (8) now (18) and Katie (4) now (14)
(My Most Precious Things)
Dx 8/11 Stage IV CRC (liver mets) CEA 2,600+
9/11 Folfiri 2/12: Failed Liver Resection
5/12 HAI pump/removed primary
4/13 Liver Resection
8/13-12/15 (10) RFAs lungs
5/17: Upper Left Lobe of lung resected.
02/18: 3 new lymph mets lung
05/18: Keytruda (MSS w/Intermediate TMB): NED CEA: 66.4, 39.2, 23.8, 13, 3.5 1.8, 1.0, 2.8 3.9, 5.0, 5.6, 1.5, .8,

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DK37
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Re: Xilonix phase III trial, for those of us who have run out of options

Postby DK37 » Tue Nov 17, 2015 12:54 pm

Thank you so much for posting all of this info Skypup!!!

Here are two column/blog posts I wrote about Xilonix a few months ago to try to explain in layman's terms how it is believed to work & with hyperlinks to original data sources. I think both links are different but important in their own ways..

http://fightcolorectalcancer.org/resear ... tion-fire/

http://adventuresinlivingterminallyopti ... tion-fire/

Cheers & thanks again,
-DK
6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
7/12 FOLFOX/FOLFIRI
2/13 NED!
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
3/15 Cetuximab
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)
MSS-CRC Clinical Trial Finder: http://trialfinder.fightcrc.org/
2016 Colondar 2.0 Model
DK37 Science Posts List

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CRguy
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Re: Xilonix phase III trial, for those of us who have run out of options

Postby CRguy » Tue Nov 17, 2015 1:17 pm

Indeed, I agree with Tom ... many thanks to you for sharing this info and your own hands-on experience with this new trial.

Best wishes coming your way skypup
Harmony
CRguy
Caregiver x 4
Stage IV A rectal cancer/lung met
14 Year survivor
my life is an ongoing totally randomized UNcontrolled experiment with N=1 !
Review of my Journey so far

lpas
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Re: Xilonix phase III trial, for those of us who have run out of options

Postby lpas » Tue Nov 17, 2015 1:24 pm

So great to hear from you, Skypup. Thanks for posting this. Sounds like it could be an important step forward.
11/14 Dx sigmoid CC @ 45yo
12/14 Colectomy + hysterectomy
Stage IIIB, T3N1bM0, 2/20 nodes, MSS, G2, KRAS(A146T), TP53, SMAD4, ERBB2, CEA 1.0
2/15-7/15 XELOX & celecoxib
2/19 clean scope
11/19 clean CT
Ongoing cimetidine & other targeted supplements
Mom to a 6 & 8yo

ieowi
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Re: Xilonix phase III trial, for those of us who have run out of options

Postby ieowi » Tue Nov 17, 2015 6:10 pm

thank you for sharing skypup.
Father 58 yo , Colon cancer IV + 4 Lymph. 7/2015
K-ras Mutant,GNAS,FBXW7,PIK3CA, MSI-low
4 cycles irinotecan+FU5
developed abdominal met + lung met...Failed
4 cycle Oxaliplatin+folfox. peri met growing...Failed
unofficial trial !!!

peanut_8
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Re: Xilonix phase III trial, for those of us who have run out of options

Postby peanut_8 » Tue Nov 17, 2015 6:40 pm

That's really exciting to see. Thanks for bringing it to our attention.

Hope everything works out for you, and that you're getting the drug and not the placebo.

Best Wishes, peanut
female, diagnosed Jan 14, RC stage 2a, age 56
MSS
April 14, 28 chemo/rad with Xeloda
June 14 adjuvant Xeloda 6 rounds
currently NED

midlifemom
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Re: Xilonix phase III trial, for those of us who have run out of options

Postby midlifemom » Tue Nov 17, 2015 7:11 pm

Skypup,
Great to hear from you.
I hope you're getting the real deal and that you have fantastic results.

I get ct scan results tomorrow morning and am in an absolute panic that life as I know it will come crashing down tomorrow. (Ct from last week ER visit showed my "multiple" mets in lungs have increased to "innumerable". Tho there is still a slight chance it's pneumonia not cancer. Anyway,,,, the reason for my saga is your post has given me hope that something else is available if I find that previous and current regimens have truly failed. Thanks so much.
Stage 3 cc - dx Jan '14 age 53, cea 2.9
t2n2m0, KRAS mutant, MSS
Folfox Feb - Aug '14
Nov '14 cea 27.7 -2 liver masses
Dec '14 left lobectomy and HAI
Jan '15 FUDR and FOLFIRI
Aug '15 fudr done, liver clear, add avastin for lungs. Cea 4.3
Feb '16 CEA rising
May '16 2 wk break then drop Iri for 6 weeks.
Jul '16 cancer grew, constricted main bile duct. Stent inserted. On break till jaundice clears. CEA climbing. Doing reduced Folfox. Allergic to Oxali.
Sep'16 chemo failed. Trial or hospice?

Ajane
Posts: 427
Joined: Tue Jul 23, 2013 3:03 am

Re: Xilonix phase III trial, for those of us who have run out of options

Postby Ajane » Sat Dec 05, 2015 10:13 pm

Thanks for posting, Skypup. Think of you of often and will continue to keep you in my thoughts and prayers. Jane
7/13, T2, G3, Ultra-low. CEA 5.7 KRAS Wild, MSS
8-9/13 6 wks Xeloda/radiation
12/13 TEM pCR NED
5/15 CEA 4.6 PET 1.5 cm met, UL Lobectomy
6-10/15: Rounds 1-2 Xelox+Avastin; 3-8 Folfox+Avastin
10/15-4/16: 12 rounds Avastin
9/2016 CEA 4.2, 12 mm AP node
11/2016 CEA 4.3. PET/CT. 16mm AP nodal met removed
4 wks chemorad
2/2017 NED CEA 2.4
Carafate to tx esophageal ulcers caused by rad
Avastin maintenance postponed

2 Corinthians 12:9

Badass
Posts: 1171
Joined: Sun Jan 15, 2012 11:42 am

Re: Xilonix phase III trial, for those of us who have run out of options

Postby Badass » Sat Dec 05, 2015 10:21 pm

Hi Skypup,
Thank you for sharing these encouraging findings. I hope you got the Xilonix and are feeling better.

Jane
R.C. 12/23/11 at age 52 T3N0M0
3/1/12 completed Xeloda and radiation
5/4/12 LAR & Ileostomy
6/7/12-10/4/12 6 rounds Xelox
11/27/12 Reversal
7/13/13 1 liver met
8/13 Met resection /hai pump
4/14 Chemo completed (Irinotecan/5fu/fudr in pump)

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vilca11
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Location: Moscow, Russia; Baltimore, USA 1992; Vilcabamba, Ecuador 2012

Re: Xilonix phase III trial, for those of us who have run out of options

Postby vilca11 » Sat Dec 05, 2015 11:48 pm

Dear Theresa, our sweet Puppy, I am so happy that you are in this trial! I happened to believe in this trial from their mid stage, when Maya informed us about it first time - I think, it is the only good one to consider on today's clinical trial scene... I so hope that you get the drug, not the placebo... I tried to send a PM to you, but you have no "contact" now, I have been thinking about you...
Please do let us know how you feel... Love, Vilca
11/2005 CC stage 1, F,50yo@dx
Mod dif adenocar, MSS, APC, TP53, CEAs1.6-4.8
1/12 1met liver@Vena Cava, RFA, 3oxi,11 5FU
8/13 2 mets same place,SBRT
4/14 2 Xeliri+Avastin
5/14 Nano Knife liver same 2 mets
6/14 2 Xeliri, ADAPT
4/15 PET, 2 same mets,Cryo Liver
5/15 MJ Oil, Herbs, Suppl, ADAPT
10/15 PET, same area, doubled in size, high SUV
10/15 RH, HAI, visceral involv., no LN
2/16 red FF, 50% red dose FUDR, CEA trends up
3/16 CT, PET, MRI L.Lobe all in small tumors
4/16 No acceptable options, going home


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