(RxWiki News) The enormous number of drugs available at the pharmacy begins to make sense when you realize that a lot of these drugs are related. Some scientists feel that despite these offerings, there's always room for improvement.
Pharmaceutical researchers constantly tinker with the previous model to fix flaws and improve how well the drug works. A recent presentation on Tomtovok (afatinib) concluded that the second generation of this drug for lung cancer is nearly ready for U.S. Food and Drug Administration (FDA) approval.
"Ask your doctor about drug trials available to you."
This phase III study was the largest so far on Tomtovok. It involved 345 patients with lung cancer with a specific mutation for epidermal growth factor receptor (EGFR).
Patients were randomly assigned to receive either Tomtovok or treatment with the current proven standard, a combination of Alimta (pemetrexed) and Platin (cisplatin).
The patients who took Tomtovok had an average period of 11 months before their cancer began to grow again (progression-free survival), while patients on the current standard treatment averaged 7 months.
Some patients with common mutations in the EGFR receptor, the Del19 and L858R mutations, had a higher average of 13.6 months before the cancer began to grow again.
Researchers noted that the Tomtovok patients were given 16 cycles on average, while patients given combination therapy only had an average of six cycles. This difference may have skewed the results.
The first two drugs to target the EGFR receptor were Iressa (gefitinib) and Tarceva (erlotinib). The ability to target EGFR is important in the type of lung cancer referred to as adenocarcinoma.
The first of its kind, Iressa, is no longer available due to the FDA withdrawing approval in 2005. While Tarceva is effective in treating cancers initially, most tumors become resistant to further treatment after a year.
Previous research on Tomtovok showed that while treatment with the drug meant more time before the cancer began to grow again, it did not increase the overall survival time for patients in the study when compared to other drugs.
This may be the reason why the study reported only the statistics for progression-free survival rather than the more commonly used overall survival numbers.
In contrast to other lung cancers, adenocarcinomas with the EGFR mutation mentioned in this study are more common in people who have never smoked tobacco.
The action of Tomtovok is related to the EGFR molecular pathway, and it also blocks two receptors called HER-2 and HER-4. Since both of those receptors are involved in breast cancer development, the drug's developer Boehringer Ingelheim also has a phase II drug trial evaluating the drug for that use as well.
Mild side effects were very common during the drug trial, with all patients taking Tomtovok experiencing episodes of diarrhea, rash, skin inflammation, nausea or loss of appetite.
Cancer treatment is no picnic, and the lead author, James Chih-Hsin Yang, MD, PhD and professor at the National Taiwan University, said a few words about the side effects during his presentation.
“Patients treated with afatinib had better lung cancer symptom control, such as diminished cough, dyspnea, and chest pain,” Dr. Yang said. “Those patients also reported that their daily lives, for example at work and performing household activities, were better with afatinib compared with [the reports from] patients in the chemotherapy group.”
Researchers involved with the study had financial ties to Amgen, AstraZeneca, AVEO, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Clovis, Daiichi Sankyo, Lilly, Merck Serono, Merrimack Pharmaceuticals and Taiho Pharmaceutical.
