Boehringer’s cancer drug enters phase III
pharmafile | November 21, 2008 | News story | Sales and Marketing | Boehringer, Cancer
Boehringer Ingelheim's new lung cancer drug Vargatef has entered phase III trials.
The drug is part of the manufacturer's burgeoning oncology pipeline, and works by inhibiting three growth factor receptors involved in the formation of blood vessels.
The three growth factors are: vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and fibroblast growth factor receptors (FGFRs).
It will be evaluated as a second-line therapy in combination with standard chemotherapy agents in patients with advanced non-small-cell lung cancer (NSCLC).
The twice-daily capsule will be tested in two studies with 2,600 patients, LUME-Lung 1 and LUME-Lung 2.
In phase I studies, Vargatef 200mg twice daily was well tolerated in combination with pemetrexed or paclitaxel/carboplatin in NSCLC patients and with docetaxel in hormone refractory prostate cancer patients.
Phase II saw NSCLC patients experiencing longer overall and progression-free survival and a higher rate of disease control compared to the overall study population.
"One in two NSCLC patients who receive treatment fail their initial therapies and remain well enough to receive additional options," says Dr Nasser Hanna, associate professor of medicine at Indiana University and principal investigator of one of the LUME-Lung studies.
The LUME-Lung studies will look at whether the addition of Vargatef to standard second-line treatment regimes will improve the outcome for these patients.
The drug may also have prospects in a number of other indications including prostate, ovarian and colorectal cancers.
Elsewhere in Boehringer's pipeline, its most advanced compound Tovok (BIBW 2992), a tyrosine kinase inhibitor, will soon enter its second trial, LUX-Lung 3 in first-line NSCLC.
It will be in competition with two existing drugs from the class, Roche's Tarceva and AstraZeneca's Iressa.
Meanwhile a new compound and potentially first-in class-molecule, polo-like kinase 1 (Plk1) inhibitor, BI 6727, will be progress to phase II.
Boehringer's move into the cancer market recognises that better targeting of tumours leads to greater revenue potential.
Dr Manfred Haehl, corporate senior vice president medicine at Boehringer Ingelheim says: "The commencement of our second pivotal phase III trial programme within the oncology portfolio, a potential first-in-class within our cell cycle kinase family and an additional phase III trial planned for Tovok reinforce the fact that our pipeline continues to move closer to our goal to develop innovative treatment options that we hope will ultimately offer patients with cancer better treatment options."
Oncology is now the second biggest therapy area by value and the fastest growing – market analyst IMS Health says it will be worth an estimated $55 billion by next year. It adds that 30% of all launches by 2010 will be in oncology and more than 50 new oncology products will be launched in the next five years.
ENDS
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