Trial of New Lung Cancer Drug OGX-427 Now Enrolling Participants

The Spruce trial, a phase II clinical trial examining the effectiveness of the cancer drug OGX-427 in non-small cell lung cancer (NSCLC), is now open for enrollment. The trial will study patients with previously untreated, advanced non-squamous NSCLC. They will receive the chemotherapy agents carboplatin (Paraplatin) and pemetrexed (Alimta) in combination with either OGX-427 or a placebo. The sponsors also plan to add the Cedar trial, which will investigate the use of OGX-427 in squamous cell NSCLC. OGX-427 inhibits Hsp27, a protein that is highly expressed in many tumor cells. The drug may be especially promising for patients without mutations that make them eligible for currently available targeted therapies.

Diagnostics Company Ready to Patent Test for Squamous Cell Lung Cancer

The molecular diagnostics company Rosetta Genomics has received permission to patent their Rosetta Lung Cancer Test. The test analyzes lung tumor tissue and distinguishes squamous cell carcinoma (SCC) from other types of non-small cell lung cancer (NSCLC). Clearly identifying a patient’s cancer subtype is becoming increasingly important for choosing an optimal treatment plan, thanks to the increasing role of targeted therapies and the growing understanding of how drug effects can differ among various cancer subtypes. For example, pemetrexed (Alimta) and bevacizumab (Avastin) benefit many NSCLC patients, but are not recommended for those with SCC. The patent allowance will permit Rosetta to develop their test for use in patients.

Maintenance Therapy with Alimta Improves Outcomes in Lung Cancer

Patients whose advanced nonsquamous, non-small cell lung cancer (NSCLC) responds to chemotherapy with pemetrexed (Alimta) and cisplatin (Platinol) appear to benefit from continuing Alimta treatment after they have achieved remission (continuation maintenance therapy). Results from the PARAMOUNT clinical trial showed that maintenance treatment with Alimta prolonged time without cancer worsening and increased survival times compared to treatment with a placebo. Continuation maintenance therapy with Alimta may be the preferable treatment choice for patients who do not experience significant toxicity from Alimta.

Afatinib May Be Candidate for First-Line Treatment in Certain Lung Cancers

Results from the LUX-Lung 3 clinical trial show that afatinib appears to be well tolerated and more effective than chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. Afatinib produced higher response rates and longer periods without cancer progression than cisplatin (Platinol) plus pemetrexed (Alimta), suggesting that it could be considered as a first-line therapy in advanced EGFR-mutant NSCLC. Afatinib, which is under priority review for approval by the FDA, may be effective in patients resistant to other EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa). However, no trials so far have directly compared afatinib with Tarceva or Iressa.

PARAMOUNT: Final Overall Survival Results of the Phase III Study of Maintenance Pemetrexed Versus Placebo Immediately After Induction Treatment With Pemetrexed Plus Cisplatin for NSCLC

In the phase III PARAMOUNT trial, pemetrexed continuation maintenance therapy reduced the risk of disease progression versus placebo (hazard ratio [HR], 0.62; 95% CI, 0.49 to 0.79; P < .001). Here we report final overall survival (OS) and updated safety data.

Pemetrexed continuation maintenance therapy is well-tolerated and offers superior OS compared with placebo, further demonstrating that it is an efficacious treatment strategy for patients with advanced nonsquamous NSCLC and good performance status who did not progress during pemetrexed-cisplatin induction therapy.

Randomized Phase III Trial of Maintenance Bevacizumab With or Without Pemetrexed After First-Line Induction With Bevacizumab, Cisplatin, and Pemetrexed in Advanced Nonsquamous NSCLC

AVAPERL evaluated the safety and efficacy of bevacizumab with or without pemetrexed as continuation maintenance treatment. In an unselected population of patients with nonsquamous NSCLC who had achieved disease control with platinum-based chemotherapy plus bevacizumab, bevacizumab plus pemetrexed maintenance was associated with a significant PFS benefit compared with bevacizumab alone. The combination was well tolerated.

Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations

The LUX-Lung 3 study investigated the efficacy of chemotherapy compared with afatinib, a selective, orally bioavailable ErbB family blocker that irreversibly blocks signaling from epidermal growth factor receptor (EGFR/ErbB1), human epidermal growth factor receptor 2 (HER2/ErbB2), and ErbB4 and has wide-spectrum preclinical activity against EGFR mutations. A phase II study of afatinib in EGFR mutation–positive lung adenocarcinoma demonstrated high response rates and progression-free survival (PFS). 

In this phase III study, it was found that afatinib is associated with prolongation of PFS when compared with standard doublet chemotherapy in patients with advanced lung adenocarcinoma and EGFR mutations.

Adding Paraplatin to Alimta Increases Survival in Lung Cancer Study

Results from a phase III clinical trial suggest that adding carboplatin (Paraplatin) to pemetrexed (Alimta) can improve outcomes in non-small cell lung cancer (NSCLC). Over 200 patients with advanced NSCLC received first-line treatment with Alimta either by itself or in combination with Paraplatin. The combination of the two chemotherapy agents extended the time before the cancer started growing again, and prolonged survival compared to Alimta alone. However, the combination treatment group had a higher incidence of serious side effects and four treatment-associated deaths.

Comparison of Combination Chemotherapy Regimens Shows No Significant Differences

Both pemetrexed (Alimta) plus carboplatin (Paraplatin) and Paraplatin plus paclitaxel (Taxol/Abraxane) plus bevacizumab (Avastin) are effective chemotherapy regimens against non-small cell lung cancer (NSCLC). However, until recently, the safety and efficacy of the two regimens had not been directly compared. To evaluate whether one regimen was superior, a phase III clinical trial determined how long patients with advanced non-squamous NSCLC remained free of either cancer progression or severe toxic side effects when treated with either of the two regimens. While patients receiving the Alimta plus Paraplatin regimen tended to have slightly longer relapse- and toxicity-free periods than those given Paraplatin plus Taxol/Abraxane plus Avastin, the difference was not very pronounced and could have happened by chance. The two regimens also did not differ regarding overall time until cancer progression, response rate and overall survival time.