New Phase 2 Trial with Immunotherapy Drugs

Berkeley, California-based Aduro Biotech, Inc., a biopharmaceutical company with three distinct immunotherapy technologies, recently announced a Phase 2 clinical trial collaboration with Merck & Co., Inc. aimed at treating patients with malignant pleural mesothelioma.

Keytruda/CRS-207 mesothelioma treatment combinationAccording to a press release issued by Aduro, the companies will investigate the combination of Keytruda/CRS-207 mesothelioma treatment. Aduro’s LADD (live, attenuated double-deleted) based immunotherapy, with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for use in patients whose pleural disease has progressed after the standard courses of treatment.

The two companies commenced a similar trial earlier this year for patients with gastric cancer.

“Data from our ongoing Phase 1 clinical trial of CRS-207 with standard chemotherapy as frontline treatment for malignant pleural mesothelioma have been very encouraging, including disease control in 94 percent of patients treated with the CRS-207/chemotherapy combination,” said Natalie Sacks, M.D., chief medical officer at Aduro.

“Based on these clinical data, as well as data from preclinical studies that demonstrate synergistic activity of CRS-207 and anti-PD-1 therapy, we look forward to initiating a Phase 2 trial to evaluate the CRS-207/pembrolizumab combination in patients with malignant pleural mesothelioma who have failed prior treatment,” she added.

The trial will include 35 victims of asbestos-caused cancer who have failed one or two prior treatments, the company explains. Most of these individuals will likely have already been treated with the chemotherapy drug Alimta™ (pemetrexed), which has been the standard first-line treatment for the disease for nearly a dozen years.

It is currently the only drug approved by the FDA specifically for the treatment of malignant mesothelioma. Currently, there is no FDA-approved second- or third-line treatments for the disease, which strikes about 13,000 individuals worldwide each year.

CRS-207 works differently than chemotherapy in that it has been engineered to express the tumor-associated antigen mesothelin, which is “over-expressed” in many cancers including not only mesothelioma but also pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.

Unlike chemotherapy drugs, immunotherapy drugs do not kill healthy cells along with cancerous cells. As such, patients experience far fewer side effects though risks are certainly present.

Many individuals who have already been involved in clinical trials with Keytruda, Opdivo, and other immunotherapy drugs have seen sizeable shrinkage of their tumors and much improved prognoses.

Merck presented its initial findings on Keytruda and the treatment of intrathoracic cancers last December at the 17th World Conference on Lung Cancer in Vienna, Austria, and the world stood up and took notice.

For mesothelioma patients who’ve seen little hope with chemotherapy treatments, immunotherapy drugs represent a virtual godsend.

Most meso patients survive little more than a year after diagnosis – often not even that long – so a drug that could greatly extend lives and improve the quality of those lives represents hope to the many individuals who have been harmed by toxic asbestos.