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Latest News from ASCO: Winners, Losers, and Also Rans

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Due to pharma’s voluntary moratorium on doling out totefuls of freebies and all the lattes you can swallow, thousands of docs, researchers, and reporters had only their sleep-deprived selves to carry from data dump to data dump at this week’s American Society of Clinical Oncology (ASCO) annual confab in Orlando, Florida.

Some 4,000 studies were reported. We humbly submit a few of the highlights.

But first a note of warning: “Success” is currently defined, for treatments of advanced or aggressive cancer, in very modest terms: by weeks, perhaps months, of survival, or survival free of disease progression, whether measured by the occurrence of symptoms or by the growth of tumors. Expectations, compared to some other clinical areas, are low.

WINNERS’ CIRCLE

PARP inhibitors

Two Phase IIs of an experimental class of drugs called PARP inhibitors reported modestly positive data for triple-negative breast cancer, raising hopes a bit for the 15 percent of breast cancer patients who are hit with this fast-growing cancer that none of the standard receptor-targeted treatments can touch.

The plainly named compounds block the PARP protein, which is used by damaged cells to repair DNA and continue growing; when a PARP inhibitor is added to chemotherapy and/or radiation, it can prevent cancer cells from regrouping.

The first study, testing PARP inhibitor BSI-201 in 116 women with triple-negative cancer that had spread to other parts of the body, reported that women who got chemo plus BSI-201 lived for an average of 9.2 months, compared to the chemo-only crowd’s 5.2 months; adding the anti-PARP drug shrunk 48 percent of the tumors, compared to chemo-only’s 11 percent.

This Phase II success is a score for Chris Veihbacher, whose aggressively acquisitive streak since taking over the top spot at struggling Sanofi-Aventis included Cali biotech BiPar, a pioneer in PARP inhibitors, including BSi-201. SA paid $500 million.

The second Phase II study tested AstraZeneca’s PARP inhibitor, olaparib, in 54 women with treatment-resistant breast cancer that is deficient in tumor-suppressing BRCA1 and 2 genes. Of those who got the higher dose of olaparib, 40 percent had tumor shrinkage.

Merck and Abbott are also grooming compounds in the PARP-inhibitor race.

Therapeutic Vaccines

BioVest International’s patient-specific vax—it contains antigen primed from your own cancer cells—prevents the relapse of follicular lymphoma by 14 months. And not a moment too soon, since Biovest filed for bankruptcy last fall.

Similarly, a gp100-marker vaccine made by the National Cancer Institute doubles response rates to standard treatment for metastatic melanoma and increased survival from 2.9 to 17.6 months.

PLACE

Herceptin (ho, hum)

Roche’s breast-cancer blockbuster won its first new use—in a subtype of stomach cancers that overexpress the her-2 protein (about 22 percent). In a 3,807-person Phase III study, the 594 patients with advanced her-2 stomach cancer lived almost for an average of 13.8 months after receiving chemo plus Herceptin, compared to the 11.1 months clocked by those in similar straits who took chemo alone. That’s 25 percent longer, as Roche will no doubt be keen to advertise—and even keener to add an extra billion or to the $4.74 billion in global sales the biologic earned last year.

Yet the drugmaker isn’t required to assess the quality of those 2.6 average extra months of life, so whether or not Herceptin, which would run you about $40,000 for 13.8 months of treatment, is truly cost-effective is anyone’s guess. (Fortunately, it’s a relatively rare disease, at least in the United States.)

SHOW

Zactima

For this first-in-class compound that combines the best of both cancer-targeting worlds by inhibiting both the cell-growing EGFR receptor and the blood-vessel-growing VEGF receptor, no. 3 is the charm. Well, maybe.

Long in development by AstraZeneca, Zactima (vandetanib) failed two Phase III studies in non-small cell lung cancer last fall. In this one, of the 1,391 patients with the advanced, recurring cancer, those on Zactima plus chemo got an average of 17.3 weeks free of disease progression, compared to the chemo alone crowd’s 14 weeks. The improvement in overall survival, though, was not statistically significant: 10.6 months versus 10 months. Will an average of a whopping 3.3 weeks free of worsening symptoms satisfy the new regime at the FDA? Stay tuned…

Lung cancer maintenance therapy

The most common cause of cancer-related death in US men, the second-most common (after breast cancer) in US women. Most are diagnosed with advanced stage disease, and most with that diagnosis live less than a year.

Pretty grim.

So the concept of maintenance therapy has taken hold among doctors recently, in an attempt to keep people alive longer—maybe long enough for a second bout of chemo and/or radiation. This idea got a lift from two studies.

Eli Lilly’s Alimta (pemetrexed), given to patients with advanced non-small cell lung cancer by an average, produced survival of 13.4 months, compared to the 10.6 months of those who receiving only “supportive care.” (Alimta-takers with the nonsquamous type of the cancer were luckier—they averaged 15.5 months.)

OSI Pharmaceuticals and Roche can boast a modest success combining their comarketed Tarceva (erlotinib) with Avastin as a maintenance treatment following chemo for advanced non-small-cell lung cancer. Those on the combo in the 768-patient Phase III had an average of 4.8 months free of disease progression, compared to 3.7 months for those on only Avastin.

That’s less than a month.

But since these targeted therapies are generally not as hard on your system as the full-on poisoning (chemo) and/or burning (radiation) that precedes them, you generally feel “better.”

LOSERS

Dendreon

The Seattle biotech’s experimental immunotherapy for prostate cancer, Provenge, after years of high drama at FDA, may have just got the sand kicked in its face. OGX-011, the lead compound of OncoGenex, when given with chemo to men with prostate cancer was associated with survival of 23.87 months, compared to 16.9 months for those on chemo alone.

Analysts and researchers are combing over the data, with some reporting that when you get deep into it, OGX-011 may have the edge on Provenge. Releasing the data that fast means OncoGenex expects big pharma partners to line up, like, right now.

ALSO RANS

Ovarian cancer marker

Early treatment of recurring ovarian cancer based on the diagnosis of raised CA125 levels offers no survival advantage over delaying treatment until actual symptoms hit. Overall survival was identical for both groups—41 months—meaning that the women who waited won an average of five extra months free of treatment and its side effects.

This was only one of the hundreds of small “target” or “marker” studies released at ASCO that will help to turn personalized medicine from a model to a practice in the treatment of cancer. Some day.

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One Comment

  1. Maen Addassi
    Posted June 4, 2009 at 1:47 am | Permalink

    I think the Avastin is a big bubble should be finished for example:
    1. Colorectal Cancer: with Oxaliplatin was not impressive. Only with Irinotecan also a negative result in early cancer
    2. Breast cancer with old product called Paclitaxel was given a good result (only progression free survival not overall survival) but in the other hand with the newest & most common drug Docetaxel with a trial called Avado trial ; it seems the result was not so impressive they tried to promoted the Hazard ratio rather than a clinical result. The median time to disease progression was 8 months with docetaxel alone, compared with 8.7 months with docetaxel plus low-dose bevacizumab, and 8.8 months with docetaxel plus high-dose Bevacizumab it is 0.8 months = 24 days !!!
    3. Lung cancer : at the beginning with Paclitaxel it was made a good survival a trial called E4599 by A Sandler published at 2006 at NEJM it is add 2 months for overall survival (from 10.2 to 12.2 ) with a double dose and of course a double cost. And at ATLAS study with Tarceva 1.3 Month more !!!
    4. Renal cell carcinoma : same story; without any advantages regarding survival
    Kindly note the British health system was refused Avastin for CRC or other indications due to lack cost effectiveness
    Is it worth this!!!

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