ASCO15: BMS' new standard for melanoma, Celldex's brain cancer vax, Clovis' ovarian cancer win
Even more exciting data out of the oncology mega-conference
Note: This post will be updated as more information comes out of the conference. You can read our writeup of Friday and Saturday's news here.
The 51st ASCO conference steamrolled ahead on Sunday, and there was plenty more exciting data to come out of the presentations, including the promise of a brain cancer vaccine and a tough new potential contender for ovarian cancer.
Let's get right to it.
1) Bristol-Myers' Opdivo combo: A new standard of care for untreated melanoma?
You might recall that Bristol-Myers Squibb's star immunotherapy Opdivo (nivolumab) had a good news/bad news sort of day on Friday as some observers voiced disappointment in the therapy's results in the most common form of lung cancer. Patients with much higher levels of PD-L1 responded quite well to the treatment, but the efficacy waned alongside patients' PD-L1 counts, raising concerns that the drug may be limited to a smaller section of the lung cancer market (although Opdivo did score a major victory with its advanced liver cancer data).
Well, those same observers were touting a combination of BMS' Opdivo and its older treatment Yervoy (ipilimumab) just one day later, with many saying that the combination of the two drugs is likely on its way to becoming the new standard of care for advanced and untreated melanoma.
Just how good were the data BMS released on Sunday? Very, very good—in a phase III trial with nearly 1,000 patients, the combo of Opdivo/Yervoy extended previously untreated advanced melanoma patients' progression-free survival to 11.5 months (as opposed to 6.9 months with Opdivo alone and 2.9 months with Yervoy alone). In addition, patients' response rate to the combo was an impressive 57.6%. Opdivo is currently cleared in the U.S. as a second-line treatment for melanoma in patients who haven't responded to Yervoy.
This is particularly good news for BMS as it could give the company an advantage over competitor Merck's Keytruda, which had a first-to-market advantage over Opdivo in melanoma.
"What this shows us is that the initial observations we made in smaller studies about the high efficacy rate of the combination are now supported by a large global study," said lead study author Dr. Jedd Wolchock of Memorial Sloan-Kettering Cancer Center in New York.
It wasn't all peachy news, though—the combo therapy also upped the risk of adverse events (55% experienced serious side effects with the combination), and more than a third had to discontinue the therapy because of that.
The FDA announced on Monday that it had accepted BMS' supplemental Biologics License Application (sBLA) for a first-line regimen of Opdivo/Yervoy in melanoma patients. The expected action date is September 30, 2015.
2) Celldex's brain cancer vaccine excites
Another treatment that had ASCO attendees buzzing on Sunday was Celldex's experimental brain cancer vaccine rindopepimut (Rintega), which continued showing promise in treatment of aggressive, recurring brain cancer.
In a phase II study, a combination of Rintega and Avastin in glioblastoma patients increased median survival by more than two months to 11.6 months compared to Avastin alone. Furthermore, the combo was well-tolerated by patients and even reduced the need for use of steroids in order to reduce brain-swelling, which could be a true boon to patients.
Even more impressive was the fact that 28% of trial participants' brain tumor progression was stymied, while 30% of these brain cancer patients were still alive after 18 months—double the number of patients who were still alive at that timeframe when treated with Avastin alone.
Lead trial investigator David Reardon described the results as "compelling."
"We’ve got a terrible unmet need where there’s no effective therapies [for recurring glioblastoma], we have a treatment that’s well tolerated and safe, there’s really no downside to it," he said.
3) Clovis lays down a challenge to big pharma in ovarian cancer
Few things make for as exciting a story as a smaller company achieving results that could challenge the big pharma status quo. And that's exactly what Clovis delivered over the weekend with promising data on its ovarian cancer candidate.
Clovis' rucaparib had some staggering results when it came to ovarian cancer response rates in a mid-stage trial. 82% of patients demonstrated an overall response, 10% had a complete response, and progression-free survival among the treated patients was 9.4 months.
The response and efficacy results were particularly pronounced in patients who either had the BRCA DNA signature or a "BRCA-like" DNA signature. That means that Clovis is setting itself up to compete with a much bigger player by the name of AstraZeneca. AZ's Lynparza received an unexpectedly fast approval for BRCA-associated advanced ovarian cancer last December, and the drug is expected to be a blockbuster for the company.
4) Other notables: Roche's non-Hodgkin's lymphoma superstar, Eisai's 'sea sponge' drug for rare cancers
There's never a dearth of data when it comes to ASCO, and this year is no exception. Here are some other promising treatments that have been highlighted at the conference:
- Japan-based Eisai's eribulin showed small (but significant) promise for patients with two rare cancers, namely leiomyosarcoma and adipocytic sarcoma (this drug was developed using sea sponges at one point and is already approved for metastatic breast cancer). These sarcomas are an area with significant unmet medical need, so even though survival rates with the investigational compound improved by just two months compared to chemotherapy, observers still lauded the results. Unfortunately, patients treated with the drug also experienced significant side effects.
- Roche/Genentech also had some impressive results for two candidates: alectinib for the treatment of ALK+ lung cancer and Gazyva, a successor to the company's mega-blockbuster Rituxan in non-Hodkin's lymphoma. Alectinib is a very targeted lung cancer therapy for a mutation that often leads to metasteses in the brain (it is already approved in Japan). Roche/Genentech also announced that Gazyva more than doubled remission periods in non-Hodgkin's lymphoma patients to just under 30 months when combined with Teva's chemo drug Treanda. The phase III study was halted early thanks to the promising results and could become one of the biggest successor drugs approved this year. Stay tuned for an interview with Genentech officials on alectinib and Roche's ambitious goal of more than 10 late-stage trials of cancer immunotherapies.