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Celgene's Revlimid Cancer Drug Trial Turns Heads

An improved version of Thalomid may be the weapon of choice against blood cancers

May 23, 2005 - Celgene's new cancer drug Revlimid is reporting the kind of clinical results that make both physicians and bureaucrats take notice.

Revlimid, a close relative to Celgene's lead drug Thalomid, has been tweaked to deliver more potent benefits and fewer side effects. Thalomid-the brand name for thalidomide, which caused severe birth defects when a British company produced it in the 1950s-won approval for sale in the U.S. in 1998 as a treatment for a skin condition related to leprosy. Many physicians have since adopted it for off- label use as a treatment for multiple myeloma, an incurable blood cancer.

Propelled by Thalomid, Celgene's annual revenues climbed from $19 million in 1998 to $377 million last year and the Summit company expects them to hit $525 million in 2005.

They could go a good deal higher if Revlimid continues to turn out clinical results like those the company disclosed earlier this month at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando. "The results look really strong," says Frank DiLorenzo, a biotech analyst with Standard & Poor's in Manhattan.

Celgene plans to file for FDA approval of the drug as a treatment for multiple myeloma before the end of the year. DiLorenzo says he wouldn't be surprised to see the agency fast-track it and send it to the market by the middle of 2006. With Revlimid and Thalomid in Celgene's portfolio, DiLorenzo thinks the company's sales could hit $1.5 billion sometime after 2010 and he has put a "buy" recommendation on Celgene stock.

"It's clearly a very interesting drug that will be used and studied in many malignancies," Dr. Roger Strair, director of hematologic malignances at the Cancer Institute of New Jersey in New Brunswick, says of Revlimid.

At the ASCO meeting, Celgene reported details of two Phase 3 clinical studies of the drug. One showed that patients who received Revlimid and dexamethasone, a steroid used as a treatment for the cancer, had remissions from the disease for median periods of 53 to 60 weeks compared with just over 20 weeks for those who took the steroid and a placebo. Celgene further found that the response rate was up to three times greater for patients taking Revlimid and the steroid versus those on the other drug combination.

A separate Phase 3 study looked at Revlimid as a treatment for 115 patients with a form of myelodysplastic syndrome (MDS), a malignant blood cell disorder that is considered a precursor to leukemia. The patients in the study all suffered from a chromosomal abnormality called 5Q deletion.

After six months on Revlimid, 66% of the patients in the trial no longer needed blood transfusions to control their disease, and the chromosomal abnormality cleared up completely in 51 patients. "At the end of the day," says Brian Gill, a Celgene spokesman, "Revlimid appears to be showing clinical benefit in a broad ranee of blood disorders."

The drug's path hasn't always been smooth. In clinical trials concluded last year, it flopped as a treatment for melanoma, a deadly skin cancer. Investors were rattled last December by reports of high numbers of patient deaths in the Revlimid MDS clinical trial. And in the trial of Revlimid on multiple myeloma patients, Celgene reported higher instances of blood clots and other side effects among patients taking the drug.

DiLorenzo doesn't think those problems will have much impact on Revlimid's future. The analyst notes that the patients it has been used on were already quite ill and he thinks the overall risk- benefit calculation still favors the drug.

"It's a very interesting drug that will be used and studied in many malignancies."

Dr. Roger Strair

Cancer Institute of New Jersey

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Teen perseveres in fight against leukemia

By DARISE JEAN-BAPTISTE
Journal Staff

ITHACA - Steer past the whirlwind of medical abbreviations and procedures, important numbers and dates and one would see Steven Quach - an optimistic 17-year old who persists in his fight against acute myelogenous leukemia.

Steven has had more than his share of ups and downs since he was diagnosed in 2003 with the disease that develops when a defect occurs in the immature cells in the bone marrow and the body cannot produce enough healthy blood cells. He has had to endure the side effects of chemotherapy, has seen strong support from his community in a 2004 bone marrow registration drive, and he has had to deal with the disappointment of an unsuccessful search for a bone marrow donor.

Steven's latest setback happened in August, when he relapsed after his cancer had been in remission for about six months. To get to a state of remission, Steven had received a first bone marrow transplant at Memorial Sloan-Kettering Center in New York City. His mother, Julie Quach, was the donor.

Assertive in his pursuit to achieve his goals and live a normal life, Steven has decided to go through a second bone marrow transplant and forego palliative care treatment options. He said he looks forward to recovering so he can go back to school, play sports and spend time with friends.

Although his life now is bogged down with doctor appointments, Steven hasn't forgotten his other obligations. This year, Steven worked with a tutor to complete two classes, and in October he took his SAT. Steven said he wanted to take more classes, but because of the physical limits the cancer put on him, he decided not to take on the full course load required to graduate from Ithaca High School.

I would do it if I thought I could finish it, he said of his classes.

Steven's illness has also brought on new beginnings. Since he was diagnosed, Steven said he has worked closely with Robert Foote, a pastor at Trinity Lutheran Church, to become more acquainted with his faith.

It helps the family know they are not alone because it is a terrifying time, Foote said.

Foote said he tries to be sober with Steven, discussing the realities of his situation with him. He said he tells Steven that he is a winner no matter what the outcome is.

Steven said his faith has helped him through his struggle with the disease, as well as helped him to see who truly cares about him and his well-being.

While the affects of Steven's illness are more physically apparent, the emotional affects of his experience are more visible in Steven's mother.

She expresses anger and despair at what Steven has had to endure. Having had a crash-course in medical terminology, Julie Quach describes in detail the various procedures doctors have performed on Steven, having been there every step of the way.

As a last resort, she donated her stem cells for Steven's first transplant, although she was not an ideal bone marrow match for him. For the second transplant, doctors from Columbia Presbyterian Hospital in New York City will use stem cells from umbilical cord blood, Steven said. The goal of the procedure is for the healthy or transplanted cells to work successfully in Steven's body, so that his cancer goes into remission.

To prepare for the second bone marrow transplant, Steven must endure an intense round of chemotherapy, which doctors have warned could damage his organs, he said.

Conscious of the risks that are involved with this form of treatment, Steven focuses on getting better.

Steven said he would like to attend Ithaca College when he graduates high school and would like to possibly pursue a career in sports management. Julie and Steven's sister Mollie are hopeful that Steven will be able to decide the career path he wants to take.

Last month, Steven was home for the first time in almost a year. He and his family hope he'll soon be home again, but this time for good.

Mollie Quach, 16, said she would like to organize another bone marrow registration drive for Steven.

She said the drive that was held last year at Cornell University and the Peking Restaurant at Cayuga Mall drew more than 200 registrants.

Ideally, someone of Asian descent would be the best match for Steven, who is Vietnamese-American. According to Asians for Miracle Marrow Matches, a bone marrow donor organization prompted to form by the lack of Asian and Pacific Islander donors in national registries, 70 percent of Asian and Pacific Islander blood cancer patients must search outside of their family for a donor.

Mollie and other family members, who were screened, turned out not to be ideal matches, she said.

Mollie said she hopes to raise awareness among minorities about bone marrow donation.

Our goal is to find a match, she said.

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