PointBreak: A Randomized Phase III Study of Pemetrexed Plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab Versus Paclitaxel Plus Carboplatin and Bevacizumab Followe…

PointBreak (A Study of Pemetrexed, Carboplatin and Bevacizumab in Patients With Nonsquamous Non-Small Cell Lung Cancer) compared the efficacy and safety of pemetrexed (Pem) plus carboplatin (C) plus bevacizumab (Bev) followed by pemetrexed plus bevacizumab (PemCBev) with paclitaxel (Pac) plus carboplatin (C) plus bevacizumab (Bev) followed by bevacizumab (PacCBev) in patients with advanced nonsquamous non–small-cell lung cancer (NSCLC).

Overall survival did not improve with the PemCBev regimen compared with the PacCBev regimen, although progression-free survival was significantly improved with PemCBev. Toxicity profiles differed; both regimens demonstrated tolerability.


Personalized Treatment Yields Results for Cancer Patients

Personalized cancer medicine uses genetic testing of patients’ tumors to guide individually tailored treatment decisions. Such tests can determine which chemotherapies would likely be most effective and whether the patient may benefit from novel drugs targeting specific mutations. One example is the case of Elizabeth Lacasia, who has advanced bronchioalveolar carcinoma, a type of non-small cell lung cancer (NSCLC). Testing revealed that she does not have any of the mutations targeted by the new drugs. Based on her test results, she was treated with a combination of Tarceva (erlotinib) and Alimta (pemetrexed) following an alternating schedule that has been proven effective for people with her cancer type. Her cancer has been in remission for 2 years.


Maintenance Therapy with Avastin-Alimta Combination Appears Effective in Advanced NSCLC

Maintenance therapy with bevacizumab (Avastin) and pemetrexed (Alimta) showed promising effects in the AVAPERL phase III clinical trial. Patients with advanced non-small cell lung cancer (NSCLC) were first treated with Avastin, Alimta, and cisplatin (Platinol). Those who responded to the treatment were either continued on both Avastin and Alimta or on Avastin only. Patients maintained on both drugs experienced more serious side effects, but went for longer without their cancer progressing (7.4 months on average, compared to 3.7 months for Avastin-only patients). While the study did not examine the benefits of Alimta-only maintenance treatment, the results suggest that the Avastin-Alimta combination is preferable to maintenance on Avastin only.


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.