Retifanlimab Wins Upfront Indication for Anal Cancer
The first indication is for upfront treatment of inoperable disease in combination with carboplatin and paclitaxel; the second is as monotherapy following progression on or intolerance to platinum-based chemotherapy.
The National Comprehensive Cancer Network recommends other PD-1 blockers for second line treatment of anal cancer, but retifanlimab-dlwr is the first one to win a formal first-line indication. Until now, standard upfront treatment has been limited to chemotherapy.
'This approval marks an important advancement as it makes a new treatment approach available for this challenging cancer,' Marwan Fakih, MD, an Incyte researcher and medical gastrointestinal oncologist at City of Hope, Los Angeles, said in a company press release.
Retifanlimab-dlwr was previously approved in 2023 for metastatic or recurrent locally advanced Merkel cell carcinoma.
The new first-line anal cancer indication with carboplatin and paclitaxel was based on the POD1UM-303/InterAACT 2 trial in 308 chemotherapy-naive, inoperable subjects, including some with well-controlled HIV infection. Patients in this trial were randomized to retifanlimab-dlwr 500 mg IV every 4 weeks or placebo on a background of carboplatin and paclitaxel for six cycles.
Median progression-free survival was 9.3 months with retifanlimab-dlwr vs 7.4 months with placebo. Overall survival (OS) assessment is ongoing, but on interim analysis, median OS was 29.2 months in the retifanlimab-dlwr arm vs 23 months, with 45% of placebo patients moving onto retifanlimab-dlwr after disease progression. OS results were not statistically significant.
Approval for the second-line monotherapy indication was based on the single-arm POD1UM-202 trial in 94 patients with disease progression on or intolerance to platinum-based chemotherapy. The dosage was again 500 mg IV every 4 weeks. The overall response rate was 14%, and the median duration of response was 9.5 months.
Serious adverse reactions occurred in 47% of patients who received retifanlimab-dlwr with chemotherapy. The most common were sepsis, pulmonary embolism, diarrhea, and vomiting, according to the company press release.
In the monotherapy study, serious adverse reactions occurred in 40% of patients, the company press release says. The most frequent, in 2% or more, were non-urinary tract infection, perineal pain, abdominal pain, anemia, hemorrhage, diarrhea, pyrexia, urinary tract infection, musculoskeletal pain, and dyspnea.
The approved dose is the same as in the trials, 500 mg IV every 4 weeks until disease progression or unacceptable toxicity for up to 12 months in the first line indication and for up to 24 months in the second new indication.
The cost of a single 500 mg/20 mL dose is $15,748.45, according to drugs.com.
Incyte has a program called IncyteCARES that offers financial assistance and other support for those who qualify. Information is available at https://www.incytecares.com/ or by calling 1-855-452-5234.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
18 minutes ago
- Yahoo
Fed minutes: Most officials worried about inflation moving higher
WASHINGTON (AP) — Most Federal Reserve officials said last month that the threat of higher inflation was a greater concern than the potential for job losses, leading the central bank to keep its key rate unchanged. According to the minutes of the July 29-30 meeting, released Wednesday, members of the Fed's interest-rate setting committee 'assessed that the effects of higher tariffs had become more apparent in the prices of some goods but that their overall effects on economic activity and inflation remained to be seen.' The minutes underscored the reluctance among the majority of the Fed's 19 policymakers to reduce the central bank's short-term interest rate until they get a clearer sense of the impact of President Donald Trump's sweeping tariffs on inflation. So far inflation has crept up in the past couple of months but hasn't risen as much as many economists feared when Trump unveiled some of his duties. The Fed left its key interest rate unchanged last month at about 4.3%, though two members of its governing board dissented in favor of a rate cut. Both dissenters — Christopher Waller and Michelle Bowman — were appointed to the board during Trump's first term. At a news conference after the meeting, Chair Jerome Powell signaled that it might take significant additional time for the Fed to determine whether Trump's sweeping tariffs are boosting inflation. When the Fed changes its rate, it often — though not always — affects borrowing costs for mortgages, auto loans, and credit cards. The Fed typically keeps its rate high, or raises it, to cool borrowing and spending and combat inflation. It often cuts its rate to bolster the economy and hiring when growth is cooling. Christopher Rugaber, The Associated Press Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
18 minutes ago
- Yahoo
Tech, chip stock sell-off continues as AI bubble fears mount
Tech stocks fell for a second day on Wednesday as investors sold off a slew of tech names amid concerns over the sustainability of the AI boom and a recent market rotation away from some of this year's biggest winners. Among the Magnificent Seven Big Tech stocks, Nvidia (NVDA) was down about 0.8%, and Alphabet (GOOGL, GOOG) stock fell about 0.6%. Amazon (AMZN), Apple (AAPL), and Meta (META) shares fell over 1%. Chip stocks Advanced Micro Devices (AMD) and Broadcom (AVGO) dropped more than 2%; Micron (MU) shares plummeted more than 5%. CoreWeave (CRWV), the AI data center company that rents computing power to Microsoft (MSFT) and Meta — making it essentially an AI pure play — also dropped nearly 4%. Palantir (PLTR), a defense tech stock that's seen a major upswing from the AI boom, sank nearly 2%, extending its recent losing streak. The rotation out of AI-linked stocks comes as sentiment soured this week on the market for artificial intelligence, fueled in part by a recent report from the Massachusetts Institute of Technology and commentary from OpenAI CEO Sam Altman. Researchers for MIT's Project NANDA authored a report released this week that said 95% of companies it studied are getting no return on AI. The findings of the report were first detailed by Fortune on Monday. That report followed commentary from OpenAI's Altman shortly after the ChatGPT-maker finished out its latest multibillion-dollar funding round, with the CEO telling reporters that he believes there's an AI bubble, a diversion from his prior characterizations. 'When bubbles happen, smart people get overexcited about a kernel of truth,' he said. 'Are we in a phase where investors as a whole are overexcited about AI? My opinion is yes." DA Davidson analyst Gil Luria likened the changing market sentiment to a pendulum. 'This is really just pendulum swinging back,' he told Yahoo Finance on Wednesday. AI stocks have taken off in recent months after a rocky start to the year. A new, cost-effective AI model from Chinese firm DeepSeek released in January cast doubt on the massive sums of money Big Tech was spending to build out AI infrastructure to power the technology — and sent tech stocks tumbling. Two rounds of earnings updates from some of the biggest AI plays in the market and more clarity on Trump's trade policies have since quelled those fears. Investors applauded recent quarterly reports from Big Tech firms Alphabet, Meta, and Amazon, which surpassed Wall Street's expectations as the companies said AI boosted their underlying businesses. That news overrode the fact that those companies also raised their forecasts for spending on AI infrastructure. 'The AI trade was getting so expensive that all it took was some comment from Sam Altman to make the investment community take some profits off the table,' Luria said. Luria added that 'the reality is that AI still has limited applications' beyond consumers talking to AI chatbots and using the tools as a search engine. Some AI bulls, however, maintain faith in the technology's ability to fuel markets to new highs. 'We are still in the early days of the AI Revolution as the use cases are just starting to massively expand as more companies recognize the value creation being driven by a handful of tech companies led by the Godfather of AI [Nvidia CEO] Jensen [Huang] and Nvidia,' wrote Wedbush analyst Dan Ives in a note to investors Wednesday. He added that 'the tech bull cycle will be well intact at least for another 2-3 years given the trillions being spent on AI.' More will be revealed when leading AI chipmaker Nvidia reports its quarterly earnings results after the bell next week on Aug. 27. Laura Bratton is a reporter for Yahoo Finance. Follow her on Bluesky @ Email her at
Yahoo
18 minutes ago
- Yahoo
California voters support EV tax incentives, but are wary of sales mandates says poll
California drivers don't want to lose their electric vehicle tax incentives, but even voters in one of the bluest states are wary about reviving plans to phase out gas cars. Voters are split down the middle on whether California should stick to its guns on its Trump-blocked plans to phase out sales of gas cars by 2035, according to an exclusive POLITICO-Citrin Center-Possibility Lab poll. Only 46 percent of the more than 1,400 registered voters surveyed said they support the policy, while 47 percent said no. Yes, there was an obvious partisan split: 60 percent of Democrats said they backed the phase-out, compared with 40 percent of independents and 31 percent of Republicans. But the results offer a note of caution for Gov. Gavin Newsom, who directed the California Air Resources Board to start writing new vehicle emissions rules after Republicans revoked the state's sales mandates for cars and heavy-duty trucks in June. 'None of us really like the idea of government intervening to take something away from us,' said Dan Sperling, a former California Air Resources Board member and director of the University of California, Davis' Institute for Transportation Studies. 'That's even the most liberal of us.' Poll respondents are more bought into Newsom's plan to backfill the soon-to-be-defunct $7,500 federal EV tax credit. Nearly two-thirds — 64 percent — said they would support state-funded tax incentives once the federal subsidy ends Sept. 30, as part of the Trump administration's ongoing attacks on clean energy policy. That question again showed a partisan divide, with 80 percent of Democrats saying they back the approach, compared with 60 percent of independent voters and just 43 percent of Republicans. But the overall result bolsters Newsom's push to backfill incentives that the Biden administration used to coax drivers off fossil fuels, as he suggested using cap-and-trade revenues last year and directed state agencies to consider in a June executive order. But Jack Citrin, a veteran political science professor at UC Berkeley and partner on the poll, said a closer look at the poll results shows that Democrats need to keep affordability in mind. He pointed to the fact that 28 percent of respondents said they'd support new EV incentives only if gas prices aren't impacted and another 20 percent said they should be reserved for low-income buyers, reflecting the fact that cost of living was the top concern of voters polled. And 64 percent of respondents said gasoline prices are putting a significant, extreme or moderate burden on their household budgets. 'That reflects a concern with the cost of all of this,' Citrin said. 'Yes, we're for environmental protection. Yes, we're for all of this, just as long as it doesn't cost a lot.' The poll comes as state agencies released a joint report Tuesday with recommendations for countering Trump's assault, calling on lawmakers to bolster tax incentives, improve charging infrastructure and regulate facilities that attract polluting trucks, but offering few specific timelines or dollar figures. CARB Chair Liane Randolph framed the report — which Newsom asked for in his June order — as a first step in the state's defense against a hostile federal government. 'Clean air efforts are under siege, putting the health of every American at risk,' she said during a press briefing. 'California is continuing to fight back and will not give up on cleaner air and better public health.' Sperling called the report a surprisingly 'modest document,' and said it lacks the specificity he hoped to see. 'The word I would use is disconcerting,' Sperling said when asked about where California stands in its fight against Trump. The POLITICO-Citrin Center-Possibility Lab poll was fielded by TrueDot, the artificial intelligence-accelerated research platform, in collaboration with the Citrin Center and Possibility Lab at UC Berkeley and POLITICO. The public opinion study, made possible in part with support from the California Constitution Center, was conducted in the field between July 28 and Aug. 12. The sample of 1,445 registered voters was selected at random by Verasight, with interviews conducted in English and Spanish, and includes an oversample of Hispanic voters. The modeled error estimate for the full sample is plus or minus 2.6 percent. The policy influencer study was conducted from July 30 to Aug. 11, among 512 subscribers to POLITICO Pro, and the modeled error estimate is plus or minus 3.7 percent. Like this content? Consider signing up for POLITICO's California Climate newsletter.
