Fwd: THE MOSS REPORTS Newsletter (06/13/03)

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THE MOSS REPORTS Newsletter (06/13/03)

 

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Ralph W. Moss, Ph.D. Weekly CancerDecisions.com

Newsletter #87 06/13/03

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ERBITUX REDUX

 

 

One of the big stories from this year’s American

Society of Clinical Oncology (ASCO) meeting concerned

ImClone Systems’ drug Erbitux (cetuximab). There are

currently at least 2,500 news stories circulating about

this agent. Much of this intense interest stems from a

controversy over alleged insider trading. However, a

lot of favorable publicity also arose as a result of

several papers presented at ASCO.

 

 

On July 30, 2001, Erbitux was hailed in a Business Week

cover story, " The Birth of a Cancer Drug. " The drug,

then called IMC-225, was celebrated as a " blockbuster "

that " halts the spread of cancer. " In an editorial

entitled " The Dawn of a New Era " , the magazine claimed

that Erbitux " seems effective against cancers of the

colon, pancreas, head and neck and lungs. " It

suggested that victory might be within sight in the war

on cancer.

 

 

Lest you think Business Week was alone in its

enthusiasm, the Associated Press ran a story on Erbitux

in May, 2001, calling it " incredibly exciting " and a

" breakthrough. " CNN’s medical correspondent claimed

that Erbitux " may shrink tumors " and " extend lives. "

The operative word here was " may " but the media was in

a typical feeding frenzy. So was Wall Street.

 

 

Bristol-Myers Squibb became so excited that it paid $2

billion for a 20 percent stake in ImClone. According

to Forbes, Bristol-Myers " already has the best oncology

sales force in the US " and would therefore have the

muscle to market the drug successfully. ImClone’s CEO

Sam Waksal said that Erbitux " is going to be one of the

biggest drugs in the history of oncology. " Now, as you

may have heard, Waksal is heading to prison for more

than seven years for his attempts to unload the stock

before it took a nose-dive last year. The same scandal

has embroiled his good friend, Martha Stewart.

 

 

Now, presumably, Erbitux has been vindicated and stocks

of both ImClone and Bristol-Myers are once again

soaring. But in reality, for all its conceptual

elegance, Erbitux has failed to live up to its promise

and publicity.

 

 

 

A Targeted Therapy

 

 

 

Erbitux does not just randomly kill dividing cells, as

conventional chemotherapy does. Instead, it was

designed on the 'smart bomb' principle, to target a

particular molecule that appears on the surface of

cancer cells. This molecule is called Epidermal Growth

Factor Receptor (EGFR) and is 'expressed,' by many

solid tumors. It is most often seen in head-and-neck

cancers, but is also found in other common solid

tumors, such as colorectal cancer, and in 40 to 80

percent of the non-small cell form of lung cancer

(NSCLC). Thus, a successful test in any commonly

occurring form of cancer would have vast implications

for the treatment of solid tumors as a whole.

 

 

There were a dozen abstracts presented at ASCO 2003

that discussed various aspects of Erbitux, but two of

these presented data on response rates, and it is these

studies that have generated most of the public comment

and stock market activity.

 

 

 

The M.D. Anderson Study on NSCLC

 

 

 

The best publicized of these (Abstract #2581) had as

its first author Dr. E.S. Kim of Houston's M.D.

Anderson Cancer Center (whose president, John

Mendelsohn, MD, invented Erbitux). There, Erbitux was

combined with the standard chemotherapeutic drug

Taxotere (docetaxel). Taxotere, one of a class of

compounds called taxanes, is the only drug approved by

the FDA as a second-line treatment for NSCLC patients

who have not been helped by prior chemotherapy. All of

the patients in this study had advanced lung cancer,

which had progressed during prior chemotherapy or else

had recurred within three months following initial drug

treatment. These patients were all chosen because

their tumors had a significant overexpression of the

EGFR molecule.

 

 

Forty-seven such patients could be evaluated for their

response to the drugs as well as for toxicity. Their

average age was 60 and their performance status was

reasonably good (an average Karnofsky performance scale

score of 80). Of these, 13 patients (28 percent)

achieved a partial response (PR), while 8 patients (17

percent) maintained stable disease for a while.

 

 

The time to disease progression was 89 days (ranging

from 17 to 411 days; still ongoing in at least one

case). This regimen was said to be " very well

tolerated with minimal toxicities. " But drug toxicity

is often in the eye of the beholder: there were, in

fact, serious grade III infections in 21 percent of the

patients, fatigue in 21 percent, and acne-like rash in

19 percent. Four patients (8 percent) had an allergic

reaction that required discontinuation of the

treatment.

 

 

The authors conclude that Erbitux " in combination with

docetaxel [Taxotere] is well tolerated and the response

rate suggests clinical activity in the second-line

setting. " A final analysis regarding the duration of

response and survival data is ongoing.

 

 

To Be Continued Next Week. (References will be given at

end of article.)

 

 

 

MR. NESI’S CRY

 

 

 

Recently, the New York Times ran one of the most

devastating Op-Ed pieces on cancer I have ever read. It

was called " False Hope in a Bottle, " and was written by

Tom Nesi. It is a powerful critique of the way that

advanced cancer is treated in academic medicine. It is

particularly critical of the new class of " targeted "

anti-cancer drugs being developed by such companies as

AstraZeneca, ImClone and Bristol-Myers Squibb.

 

 

The article concerns the treatment Mr. Nesi’s wife,

Susan, received for her brain cancer. In the later

stages of her illness, she received the recently

approved drug Iressa. Nesi notes that similar drugs

such as Erbitux and Avastin are now speeding through

the FDA approval process.

 

 

It is hard to argue against making new cancer drugs

available to the desperately ill, " he writes.

" Certainly, these drugs are a step in the right

direction in the fight against the disease. " He

believes that these drugs do extend life by a few

months. But he continues: " I think we need to ask

ourselves whether offering terminal patients limited

hope of a few more months is really beneficial. The

question is not whether days are extended, but in what

condition the patient lives and at what emotional and

financial cost. "

 

 

Oncologists often talk in dry-as-dust terms about

" tumor shrinkages, " " responses " and the other arcane

indicators of benefit. But Nesi notes, ironically,

that " according to the medical profession, the

experimental treatment had worked. " Susan lived almost

three months longer than the average patient with

glioblastoma.

 

 

" Somewhere in some computer database, " he adds,

" Susan’s experimental regimen will be counted a

success. She was a 'responder.’ And therein lies the

terrible truth behind the approval of 'miracle drugs’

on the basis of 'tumor shrinkage’ or 'extended days.’

Susan's life was extended. But at what cost? " he asks.

 

 

It is easy to calculate the financial cost. In Susan

Nesi’s case it added up to at least $200,000 for a

year-and-a-half of treatment. " During those final

months, Nesi wrote, " we incurred expenses for four

ambulance trips, two weeks in a critical care center, a

full-time home health-care aide, a feeding tube and

electronic monitor, home hospital equipment,

occupational therapists, social workers and

medication. " He had to hire someone just to handle all

the bills.

 

 

" I still hear the words of my wife's surgeon after her

disastrous third surgery,” said Nesi: “ 'We have saved

your wife's life. . . . We have given you the ability

to spend more quality time with your loved one.’ And

the words she scribbled on a notepad two weeks later:

'depressed . . . no more . . . please.' "

 

 

The article is a cry from the heart for cancer doctors

to pause in their headlong pursuit of largely

meaningless goals, such as transient and partial tumor

shrinkages. One hopes that the executives of the

companies that produce these drugs will open their

minds and hearts, along with their morning papers, and

pay special attention to Mr. Nesi’s appeal. In this

case, they might. For Tom Nesi, ironically, is the former

director of public affairs at Bristol-Myers Squibb.

 

 

Nesi, Tom. False hope in a bottle [op-ed], New York

Times, 06/05/03:

http://www.nytimes.com/2003/06/05/opinion/05NESI.html

 

 

References for the Erbitux article will appear next

week.

 

 

NOTE: There is an excellent summary of the recent ACAM

conference at the website of Ann Fonfa:

http://annieappleseedproject.org/amcolforadin1.html

 

 

 

DEPARTMENT OF CORRECTIONS

 

 

 

Last week I referred to NABCO as the National

Association of Breast Cancer Organizations when I meant

the National Alliance of Breast Cancer Organizations.

I also referred to the incoming patient representative

on the Oncologic Drugs Advisory Committee as a

hematologist. The current representative is Jody L.

Pelusi, F.N.P., Ph.D. of the Northern Arizona

Hematology and Oncology Associates, Sedona Cancer

Center. Her replacement at the end of this month has

not been announced.

 

 

 

 

--Ralph W. Moss, PhD

 

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IMPORTANT DISCLAIMER

 

 

The news and other items in this newsletter are

intended for informational purposes only. Nothing in

this newsletter is intended to be a substitute for

professional medical advice.

 

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