Committee: NSCLC Study Should be Halted Due to Lack of Efficacy

“An independent data monitoring committee recommended that a phase 3 study designed to evaluate the combination of onartuzumab and erlotinib in a subset of patients with non–small cell lung cancer be stopped due to lack of clinically meaningful efficacy, according to a press release issued by the drugs’ manufacturer.

“The randomized, multicenter, double-blind, placebo-controlled MetLung study compared the humanized monoclonal antibody onartuzumab (MetMab, Genentech) plus the protein kinase inhibitor erlotinib(Tarceva, Genentech) vs. erlotinib alone in patients with previously treated advanced NSCLC whose tumors were MET-positive.”

Motesanib Plus Carboplatin, Paclitaxel Extended Survival in NSCLC

“The addition of motesanib to carboplatin and paclitaxel improved OS, PFS and response rates in patients with nonsquamous non–small cell lung cancer, according to results of a phase 3 study.

“The subset analysis of the MONET1 trial included 227 Asian patients with stage IIIb/IV or recurrent disease who had not received prior systemic therapy for advanced NSCLC.”

Ipsen Announces Positive Top Line Results from Phase III Clinical Study of Decapeptyl® (Triptorelin Pamoate) 11.25 mg Administered Subcutaneously in Patients with Prostate Cancer

“Ipsen today announced that the phase III clinical trial evaluating Decapeptyl® (triptorelin pamoate) 11.25 mg administered subcutaneously in patients with locally advanced or metastatic prostate cancer has met its primary endpoints. The full study results will be presented this year during a medical congress.

“Based on these results, Ipsen intends to apply for the addition of the subcutaneous route, alongside the intramuscular route, to the label of triptorelin pamoate 11.25 mg.”

Ipilimumab Shows Hints of Efficacy in Metastatic Castration-Resistant Prostate Cancer

“Key Points:

“Ipilimumab failed to meet the primary endpoint of overall survival in a phase III study in metastatic castration-resistant prostate cancer previously treated with docetaxel.

“The drug improved progression-free survival and PSA response.

“Subgroup analyses suggested that the presence of visceral metastases had a negative impact on survival.”

Lung Cancer Drug Disappoints in 2 Late-Stage Trials

In a recent phase III clinical trial, the cancer drug dacomitinib was no more effective than a placebo at prolonging survival for patients with advanced non-small cell lung cancer (NSCLC) for whom standard therapy had failed. Like the targeted drugs erlotinib (Tarceva) and gefitinib (Iressa), dacomitinib blocks the protein EGFR, but it also inhibits a number of similar, related proteins. Another trial compared dacomitinib to Tarceva in NSCLC patients who had previously received at least one EGFR inhibitor. Dacomitinib did not increase time without cancer worsening compared to Tarceva. Results from a third phase III trial, which compares dacomitinib to Iressa in NSCLC patients with EGFR mutations, are expected next year.

Interim Results from Lung Cancer Clinical Trial of Tivantinib Remain Ambiguous

An ongoing clinical trial is evaluating the effects of cancer drug tivantinib in non-small cell lung cancer (NSCLC). The trial studies patients with advanced non-squamous NSCLC who do not have any mutations in the EGFR gene. Patients receive erlotinib (Tarceva) either by itself or in combination with tivantinib. Enrollment in the trial was stopped because rates of interstitial lung disease (ILD), which can cause lung scarring, may be higher in patients receiving tivantinib. (No such increased levels of ILD were seen in a different trial using tivantinib.) For the patients already enrolled, overall survival, time without cancer worsening, and percentage of patients experiencing tumor shrinkage all seem increased in tivantinib-treated patients. However, it is not yet clear whether these effects are indeed caused by tivantinib or are due to chance.

Xalkori More Effective than Chemotherapy as Second-Line Treatment in ALK+ Lung Cancer

The ALK inhibitor crizotinib (Xalkori) has shown effectiveness in patients with non-small cell lung cancer (NSCLC) who have changes in the ALK gene that make the gene overactive (so-called ‘ALK-positive’ patients). A recent clinical trial compared Xalkori to chemotherapy as a second-line treatment in these patients. Over 300 patients with ALK-positive advanced NSCLC who had undergone one previous round of chemotherapy were treated either with Xalkori or one of the chemotherapy drugs pemetrexed (Alimta) or docetaxel (Taxotere). Tumors shrank in 65% of Xalkori-treated patients, compared to 20% of those receiving chemotherapy. The Xalkori-treated patients also went longer without their cancer worsening, experienced fewer symptoms, and reported higher quality of life.

Clinical Trial to Examine Effectiveness of Lung Cancer Vaccine TG4010 in Select Patients

A new clinical trial will examine the effectiveness of the lung cancer drug TG4010. TG4010 acts like a vaccine: it sensitizes the immune system to MUC1, a protein expressed in high levels on many lung tumor cells, and thus primes the immune system to attack these cancer cells. A previous trial suggested that TG4010 is most likely to be effective in patients with low levels of a certain kind of immune cell called triple-positive activated lymphocytes or TrPAL. In the new trial, patients with advanced non-small cell lung cancer (NSCLC) whose tumors express high levels of MUC1 and who have low levels of TrPAL will receive either TG4010 or a placebo along with their standard treatment.

New Clinical Trial Examines Lung Cancer Drug Bavituximab

The makers of the cancer drug bavituximab are initiating the SUNRISE trial, a phase III clinical trial investigating the efficacy of the drug against non-small cell lung cancer (NSCLC). Patients with advanced non-squamous NSCLC whose cancer has progressed after first-line treatment will receive either bavituximab plus docetaxel (Taxotere) or Taxotere by itself. Bavituximab inhibits phosphatidylserine, a protein found on the surface of tumors and tumor-associated cells that acts to suppress the body’s immune reponse. By blocking phosphatidylserine’s action, bavituximab allows the immune system to continue attacking the cancer. To find out more, patients can go to