ASCO Soundbites, vol. 3: Real-time approvals, Pfizer's second rodeo and 'the busiest ASCO ever'

With ASCO nearing its official close, it's time to round up our favorite quotes from the weekend—a process that's become somewhat of a tradition for us over the last couple of years. Read on to see the most colorful things pharma executives had to say about the conference, their data, the FDA, genetic testing, and everything in between. 

The way Johnson & Johnson sees it, its latest prostate cancer data for Zytiga successor Erleada is unique in one key way that should make things "easy for clinicians," Mark Wildgust, vice president of global medical affairs for oncology at J&J’s Janssen, said. "This is simple. Every man who has metastatic prostate cancer, whether they had surgery, radiation, some ADT, maybe some docetaxel—when you give them apalutamide, they live longer," he said.

Adding Keytruda to chemo may have cut the death risk in half for patients with previously untreated non-small cell lung cancer, but not so in gastric cancer. A study Merck presented over the weekend showed Keytruda and chemo together actually did worse than chemo on its own, reminding industry watchers that "we’re quite early in the total exploration in the place of immuno-oncology therapy," Roy Baynes, M.D., Merck SVP and head of global clinical development, told us. Asked which Keytruda-chemo combo results he’s most eager to see next, he joked that, "I’d like to see all of them," before highlighting trials in bladder cancer and breast cancer. "Hopefully we’ll have answers in the not-too-distant future," he said.

Pfizer’s recently launched Talzenna is competing against some stiff PARP competition in breast cancer, but "the nice thing about our experience … and this kind of precision medicine approach" is that "this isn’t our first time at the rodeo," Andy Schmeltz, global president and general manager of Pfizer’s oncology unit, said. When the company was trialing targeted lung cancer drug Xalkori, only 11% of patients were being tested for the ALK gene. Today, that number is more like 85%. "We’ve been on that journey," Schmeltz said.

Speaking of driving testing, that’s exactly what AstraZeneca and Merck’s new pancreatic cancer data for Lynparza will do, predicted Dave Fredrickson, EVP and global head of AstraZeneca’s oncology business unit. An OK for the partners would "create the imperative to make sure that we’re testing for BRCA outside of just for women’s cancers," he said, adding, "I think that’s a very exciting turn also in the narrative and the story around what we’ve understood around the science behind BRCA."

AbbVie and Roche didn’t have the typical ASCO experience when it came to unveiling data on their Venclexta-Gazyva combo in first-line chronic lymphocytic leukemia. Normally, companies make their presentations at the meeting in front of an audience of oncologists, so doctors have been briefed by the time an approval comes. But thanks to the FDA’s new Real-Time Oncology Review program, which handed the drugmakers a green light for the pairing in mid-May, "the sequencing" was "a little bit different," Rod Humerickhouse, M.D., Ph.D., asset strategy leader at AbbVie, said, adding that "there wasn’t a public forum" for the data at the time of approval. "The FDA did not coordinate with ASCO," Danelle James, M.D., head of clinical science at AbbVie’s Pharmacyclics, joked. "No, they did not," Humerickhouse answered, "and we’re happy about that."

Was this year’s ASCO a "quiet" one? Not to Regeneron. "We’re in launch mode. This is our first ASCO after the approval" of PD-1 inhibitor Libtayo, E.B. Brakewood, VP and general manager of Regeneron’s oncology business unit, said. "This is anything but quiet. To us, this feels like the busiest ASCO ever."

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